Roche Diagnostics Corp. Recalls
Showing 41-60 of 81 recalls
Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and Cobas c 501clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.
Expired product (dated 2006.06) was shipped as replacement for recalled product.
Consignees were notified by phone and sent a recall letter dated 7/21/06 via fax, which instructed them to discontinue use of these lots of product and to discard them.
Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic.
A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported.
A recall notification letter dated 4/12/06 was sent to each customer instructing them to discontinue use of this lot of product.
Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Catalog numbers 12236931001 and 03670325001
The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument.
Consignees were notified by letter dated 4/4/06 to notify customers of the problem and provide a work-around.
Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680.
A software defect will allow the reporting out of believable, but clinically significant, erroneous results if the analyzer is in operation and a channel has been masked or not requested over a period of time.
Recall letters dated 8/6/04 were sent to each customer advising them of the problem and giving instructions on how to avoid it.
Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216.
May have tobramycin over-recovery at the trough level.
Consignees were notified via phone and faxed recall letter on or about 2/10/06.
Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in 10 x 10 box (10 cartidges per blister pack; 10 blister packs per box; Manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 150.0157.
Lack of assurance of sterility.
The firm issued recall letters dated 5/17/04 to all users. A dear doctor letter issued to prescribers instructing them to discontinue prescription of the glass cartridges.
BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.
The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.
Recall letters dated 2/15/05 are being sent to each consignee instructing them to discontinue use of pre-programmed HCV parameters with the Amplicor heatitis C virus test and that previous test results within a specific range be reviewed by a physician.
Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.
Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2.
Consignees were notified via letter dated 12/9/05.
Roche brand Elecsys Troponin T; catalog number 2017644.
A false negative result may be reported.
Recall letter dated 1/31/06 was issued to each customer instructing them to stop using, and to discard, the product.
Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003.
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.
Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001.
If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.
Consignees were notified via letter dated 4/18/05, which included instructions on how to inspect their unit for damage, and how to prevent future damage.
Roche Elecsys total PSA, catalog number 11731262322.
There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.
Consignees were notified of the incompatibility via reagent bulletin dated 12/7/05.
ACCU-CHEK Instant Meter; Catalog numbers 914 and 924.
The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip opening has been previously flooded with excess control solution or blood.
A recall letter dated 5/18/05 was sent to health care professionals informing them of the problem and reqeusting them to provide a letter to their patients alerting them to the issue and how to avoid it. A notice of the problem will be placed in all packages of strips in the future.
Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.
The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.
The firm began notifying family members of pediatric patients via phone on 7/15/05 and immediately began shipping a recall letter and 10 packs of replacement adapters to each pediatric user. Attending physicians were for these pediatric patients were notified the week of 7/18/05 via phone and follow-up letters were sent to these physicians. The firm is issuing a press release on 7/28/05. Only these replacement adapters are being sold by Disetronic to users of any age ordering new adapters.
ACCU-CHEK Compact Meter; catalog number 3183572.
The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for the sample, or if excess control solution or blood has been applied to the test strip.
A recall letter dated 5/18/05 was sent to health care professionals informing them of the problem and reqeusting them to provide a letter to their patients alerting them to the issue and how to avoid it. A notice of the problem will be placed in all packages of strips in the future.
Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 04344456001.
Lack of adequate manufacturing controls.
Consignees were notified via letter dated 5/3/05. Customers were requested to discard their device and to respond to Roche for a refund. The firm''s internet support site for the system is being turned off.
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
A hardware/software problem will result in low elution volumes and bias sample results for various protocols.
Consignees were notified via recall letter dated 8/6/04.
ACCU-CHEK Inform meter; catalog No. 3035123.
Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.
A recall notice dated 6/30/04 was sent to each customer instructing them on proper cleaning methods, asking them to inspect their units for damage, and providing warning stickers for attachment to the base units.
Roche brand Cardiac Reader.
Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.
User hospitals were notified via phone, letter and fax (beginning on 12/3/04) a copy of the recall notification on December 3, 2004, which instructed them to immediately cease using the device. The firm issued a press release on December 8, 2004.
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
Test results may be adversely affected by software shutting down the cooling blocks in systems with software version 3.09.
Consignees were notified via letter dated 11/5/04, which provides the user with a workaround.