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.
FDA Recall Z-0893-05 · Posted 2005-06-16
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Recalling FirmAbbott Health Products, Inc.
Recall StatusTerminated
Product CodeJHI
Date Initiated2005-03-24
Date Terminated2012-01-23
Product Quantity2496
Reason for Recall
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Domestic , US Goverment and International ditribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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