Radiometer America Inc Recalls
Showing 41-55 of 55 recalls
Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series.
Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.
The customers were apprised of this situation with a recall letter issued by the firm on 6/17/2005. In addition, new Operators Manuals were sent to the customers. In the letter, the customers were advised that a Service Engineer would be contacting them shortly in order to arrange for the installation of the software upgrade. The firm''s Service Engineers visited each customer location and installed software upgrades. Version 3.831 software was installed on the 700 Series Analyzers and Version 4.14 was installed on the 800 Series Analyzers. According to the firm, these software corrections were verified as having been completed by 3/10/2006.
Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box.
The package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit) testing. The range stated on the package insert was too low to generate accurate Hct test results (The control ranges were acceptable for the glucose and lactate testing).
The firm apprised their customers of this situation with a letter dated 5/24/2005. The letter requests that the customer remove the old (incorrect) package insert and replace it with a new (correct) insert which accompanied the customer letter. Should the customer have any questions, or need additional package inserts, the letter provides a toll-free contact telephone number.
ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.
The firm initiated this recall on 10/31/2005, at which time a Field Action Note was issued to their Service Reps. The notice instructed the service personnel to upgrade all ABL800 analyzer units presently running with software version V5.21 to the new version V5.23, in order to correct this problem. The Service Personnel began conducting visits at each customer site on 10/31/2005.
Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are placed in the capillary tube kit which also contains: capillary tubes, end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on the kit model. Each bag contains: 110 Green caps per bag and 160 Red caps per bag.
Capilliary end caps, an accessory for ABL blood gas analyzers, leak blood from capillary tubes during transport.
The firm notified their customers of this recall action with a letter dated 3/22/2006. The letter was accompanied by a single bag of new end caps. The letter informs the customers of the ''leakage'' problem and asks that the customer examine their inventories and discard any of the referenced end caps found on-hand at any of their various locations. The letter also includes a response form to be faxed back to Radiometer indicating the amount of replacement capillary end caps required by the customer in addition to the one bag received. The recalling firm also notified the customers that the suspect end caps will all be replaced ASAP.
ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Part Number: 906-018.
The dimensions and shape of the analyzer adaptor do not fit the analyzer tubes or probe, causing air to be aspirated with the blood sample and causing a deviation in the pO2 sample results.
The firm issued a letter to their customers dated 6/9/2005. The letter reports the defect with the ABL5 Capillary Adapters and informs the customers that Radiometer reps will be replacing all of the customers'' ABL5 adaptors ASAP. The letter is accompanied by a single bag of new adaptors for the customers'' ''immediate needs'' and also provides a faxed response form which the customer can use to request additional adapters as required. In addition, should the customer choose to use the old adapters in their possession, the letter stresses and reiterates the ''Precautions and Warnings'' applicable for use of the ABL5 should air bubbles be observed in the measuring chamber by the user/operator.
Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box.
Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument.
Following the receipt of three (3) customer complaints, on 9/14/2005, the firm issued an E-Mail notification [Management Cover] to their Service Personnel on 9/19/2005. The Management Cover instructed the service personnel to check the electrodes located at their stock and their customer locations; put all electrodes, which cannot be inserted in their call-back stock; and provide for credit to their customers through normal channels. The Service Personnel in turn, contacted their customers via telephone on or around 9/20/2005 and asked that they check their inventories for the presence of any electrodes which would not fit in the analyzer and return any such electrodes to Radiometer America for replacement
Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic.
Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.
The firm initiated this recall with letters to their customers on 3/2/2005. After this notification, the firm''s Field Service Reps visited each affected customer and updated their software to version 2.42. According to the firm, these actions took place from 3/12/2005 thru 4/15/2005. The Field Reps. of Radiometer America reported to Radiometer Medical ApS in Denmark that the necessary corrections had been competed as of: 4/15/2005.
SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be included in capillary tube kits as follows: Clinitubes Kits: 942-890 (D941P-240-85x1), Lot Code: R0048; Clinitubes Kits: 942-892 (D957P-70-100x1), Lot Codes: R0045 through R0050; Clinitubes Kits: 942-893 (D957P-70-125x1), Lot Codes: R0058 through R0063; Clinitubes Kits: 942-898 (D957P-70-70x1), Lot Code: R0019. Each of the kits listed above contains one (1) bag of Capillary Caps, 905-787.
Leaking Capillary Caps- The dimensions and shapes of the capillary caps do not fit the capillary tubes correctly. This can cause the capillary tubes to leak.
The firm sent a recall letter to their customers on 6/29/2006. The letter identifies the problem and kit numbers and lot numbers for the affected kits, and as well as the Lot Numbers for the defective 905-787, capillary caps subject to recall. The letter requests that the customers: 1) Examine their inventories for the presence of the affected lot numbered products; 2) Identify and discard any of the recalled bags contained in the kits or ordered separately; and 3) Return the attached FAX FORM indicating the amount of replacement product required and the address to which the replacement product should be mailed. The letter also provides a telephone number to reach the firm''s Technical Support Department should the customer have any questions concerning the recall letter.
TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use.
Radiometer contacted the affected U.S. customer and informed them of the recall via telephone on September 27, 2011. Radiometer requested the return of the affected product received from the firm. For questions call (440) 871-0463.
Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) membranes per box. Calcium membrane jackets that are used in the ABL505/555, EML105, ABL600, ABL700 Series and ABL800 Analyzers for InVitro testing of samples of whole blood for the parameters pH, PO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, CCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the h
Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of fluids between the wrinkles can cause a positive bias resulting in calcium measuring errors. This situation poses a risk to the safety of patients, particularly when the measurement results are used
The firm, Radiometer America, sent a "MEDICAL DEVICE FIELD CORRECTION" letter dated April 14, 2011, to all affected customers. The letter describes the product, problem and the actions to be taken. The letter provides the customers with a series of steps to be taken when replacing the Calcium Membrane (Until further notice the above procedure must be carried out when replacing the Calcium membrane). The letter also provides quality control instructions for verifying calcium performance. Additionally, the customer is required to manually adjust the upper and lower QC limits on the analyzer in relation to the limits printed on the insert sheet in order to detect the bias during quality control measurements (This must be done for every lot of QC ampoules used, and for any new lot of ampoules installed). The letter asks that each customer complete and return the attached form via fax to 440-871-0463, in order to verify that the notification letter was received. Questions should be directed to the firm's Technical Support staff at 800-736-0600, Opt. 4.
D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer.
The CI membrane units generate too low values for status and sensitivity during calibration.
The recalling firm sent a letter, dated 2/05, to all of their consignees.The letter instructed the customers to discontinue use of the product and discard any remaining stock which they had on hand. The letter was accompanied by replacement chloride membranes to replace the customer''s portion of the suspect lot.
Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer
Incorrect FI02 values: programming issue can cause incorrect values to be transmitted to the LIS when : 1)- The FIO2 result is edited in the manual sample processing mode--2)- An existing result is opened and FI02 is then edited and sent.....In both cases RADIANCE will transmit the original FI02 value, not the value that was edited.
The recalling firm initially contacted their customers and informed them of the software problem and the upcoming field correction for the software, via telephone on 7/6/2006. A follow-up letter dated 7/21/2006, was also sent to the customers.
SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each carton contains ten (10) boxes and each box contains 100 pouches. The product subject to recall is identified with the following Part Numbers/Order No: 956-610, 956-612, 956-614, 956-616, and 956-623.
Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps.
The firm sent a recall letter to their customers on 7/18/2006. The letter identifies the problem, as well as the Part Numbers and Lot Numbers for the defective safePICO syringes subject to recall. The letter requests that the customers: 1) Examine their inventories for the presence of the affected part numbers and lot numbers; 2) Identify and discard any of the affected product found on-hand; and 3) Return the attached FAX FORM indicating the amount of replacement product required and the address to which the replacement product should be mailed. The letter also provides a telephone number to reach the firm's Technical Support Department should the customer have any questions concerning the recall letter.
D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.
The recalling firm notified their distributor/customers of this recall, via telephone on 6/17/2005, at which time, the customers were asked to destroy any and all suspect reference membranes found on-site and at their subaccount customer locations.
D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.
The firm contacted their customers and informed them of this problem and provided a workaround procedure, in a a letter dated 1/12/2005. A ''Field Action Notification'' (FAN) was issued to the firm''s Field Service personnel on 1/21/2005. The letter instructs their personnel to update the NPT7 application software on all units to V3.05 and to hand over a copy of the letter ''Changes related to the Qualicheck2+ and NPT7,'' to the user/customers. In addition, the firm''s personnel were instructed to remove any of the suspect cartridges found on-hand at each customer location; destroy them;and replace them with different lot numberd product.