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

FDA device recall Z-0127-2008 · posted 2008-01-24 · Terminated

Recall details

Recalling firm

Abbott Laboratories

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.

Action taken

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.

Root cause

Process change control

Status

Terminated

Product code

LOM

Quantity affected

1,722 packs

Distribution

Nationwide Distribution, including Puerto Rico.

Date initiated

2007-10-01

Date posted

2008-01-24

Date terminated

2008-05-09

Location

Abbott Park, IL