Abbott Health Products, Inc. Recalls
Showing 1-10 of 10 recalls
AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent.
Abbott Diagnostics is investigation a recent increase in customer complaints for AxSYM calibration error code 1048 and controls out of range when using AxSYM Total B-hCG reagent lots. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.
Abbot Health Products, Inc. informed and instructed their customers via Device Recall Letter to Identify if they have used or have inventory of the affected product. Discontinue use of and destroy any remaining inventory of reagent lots listed in the Device Recall letter according to their laboratory procedures. Record the quantity of the recalled reagents currently in inventory in their facility that will be destroyed on the attached reply form and fax the form back to Abbott 1-800-777-0051. (US only) Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.
IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl Phosphate and one bottle of Specimen Diluent
Abbott Diagnostics is investigating a recent increase in customer complaints for IMx calibration error code 157 and controls out of range when using IMx total B-hCG Reagent Lot 25459Q100. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.
Abbot Health Products, Inc informed and instructed their customers via Device Recall Letter to Identify if they have used or have inventory of the affected product. Discontinue use of and destroy any remaining inventory of reagent lots listed in the Device Recall letter according to their laboratory procedures. Record the quantity of the recalled reagents currently in inventory in their facility that will be destroyed on the attached reply form and fax the form back to Abbott 1-800-777-0051. (US only) Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.
IMx HAVAB Controls In Vitro Test
Abbott identified through investigational studies that IMxHAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMxHAVAB Package Insert.
Abbott identified through investigational studies that IMx HAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package insert. If a control value is out of the specified range, the assay run is invalid and assay recalibration may be indicated. If the control values are within range as specified in the package insert, the assay run is valid and the patient results are not impacted.
AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Assay may give elevated patients results.
Device recall letters dated 8/24/2004 were sent to all customers. Customers were instructed to identify if they have used, are currently using, or have inventory of the AxSYM Total B-hCG Reagent lots. Discontinue use of and destroy any remaining inventory of the lots according to their laboratory procedures. Record the quantity currently in their facility that will be destroyed on the attached reply form and fax the form to Abbott at 1-800-777-0051 (US only). Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.
IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with recalcified human plasma and the preservative is Sodium Azide. The Negative Control is non-reactive for HbsAG, HIV-1, Anti-HCV, anti-HiV-1/HIV-2 and IgG antibody against HAV. The Positive Control is recalcified human plasma for anti-HAV diluted with Negative Control.
Abbott identified through investigational studies that IMx HAVAB Controls lot 18220Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package Insert.
Device recall letters were dated 10/27/2004. Letter was mail to customers asking to destroy and discontinue use of device. On hand inventory information was requested to be forward to Abbott at 1-800-777-0051 (U.S. only).
AxSYM Total B-hCG Reagent Pack
Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.
Device recall letters dated 7/7/04 were sent to all customers. Customers were instructed to identify if they have used, are currently using, or have inventory of the AxSYM Total B-hCG Reagent lots. Discontinue use of and destroy any remaining inventory of the lots according to their laboratory procedures. Record the quantity currently in their facility that will be destroyed on the attached reply form and fax the form to Abbott at 1-800-777-0051 (U.S. only). Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.
AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064
Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.
The Important Information Letter dated 11/17/03 was mailed to all ADx, TDx/TDxFL and AxSYM TCA reagent customers. The letters were sent to customers by Federal express Priority mail. The letter recommended contacting all customers who have received the reagents within the last 15 months.
TDx/TDxFLx Opiates Reagent, Product list number: 9673-60
Abbott Diagnostics Division has found that the oxymorphone cross-reactivity information in the 'Specific Performance Characteristics' section of the TDx/TDxFLx Opiates Reagent package insert (commodity number 32-2087/R5) does not match the current product performance.
A Device Correction Letter dated 5/28/04 was mailed to all customers. The letter explained the reason for the recall and provided specific instructions.
AxSYM Tricyclic Antidpressants Reagent. Distributied under the following label: AxSYM Abbott Laboratories USA, North Chicago, IL 60064
Unexpected false positive TCA results
A Device Correction letter was mail to all customers on 12 /11/02. The letter explained the reason for the recall and provided specific instructions.
AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories USA, North Chicago, IL 60064
Results lower than package insert ranges
Device Recall Letters were mailed to all Abbott customers World Wide on 12/11/02. The letter instructed to check their inventory for the recalled product, discontinue use and destroy it according to their laboratory procedures. If the product was forwarded to another laboratory, please provide them with a copy of the letter.