Z-0127-2008

Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B...

Name: Z-0127-2008 Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B...
Creator: Abbott Laboratories
Published: 2007-10-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-10-01 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B Surface Antigen (Anti-HBs); Abbott Laboratories... on 2007-10-01. The reason FDA records is "Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components, which could result in both false reactive and false nonreactive specimens". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0127-2008
Status: Terminated
Initiated: 2007-10-01
Posted: 2008-01-24
Terminated: 2008-05-09
Recalling firm: Abbott Medical
Product: Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B Surface Antigen (Anti-HBs); Abbott Laboratories, Abbott Park, IL 60064
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Reason for recall: Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components, which could result in both false reactive and false nonreactive specimens.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: Abbott sent a Product Recall letter, dated 10/01/07, to all AxSYM AUSAB customers that received the affected lots of product, informing them of the manufacturing error that resulted in both false reactive and false nonreactive specimens. The letter provided the assay bias for both lots. The accounts were requested to examine their inventory for the affected lots; destroy any packs found; record the number of packs destroyed on the Customer Reply Form; and fax the completed form back to Abbott at 1-800-777-0051 prior to 10/12/07. They were also requested to evaluate patient results generated with these lots in alignment with the information provided in the letter to determine if additional action is necessary. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the lots; and to retain a copy of the letter for their records. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT.
Quantity in commerce: 1,722 packs
Distribution: Nationwide Distribution, including Puerto Rico.
Product codes and lots: Lot Numbers: 49535M100 and 55451M200

Product code LOM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)