Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA The Abbott R

FDA device recall Z-1399-2011 · posted 2011-02-23 · Terminated

Recall details

Recalling firm

Abbott Molecular

Reason for recall

Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package insert.

Action taken

Abbott Molecular sent a Field Advisory Notice letter to all RealTime HIV-1, CT/NG and HBV assay customers on December 20, 2010, informing them that internal testing identified the potential of under filled and over filled enzyme vials which may result in obtaining less than the total number of tests per kit as described in the package insert. The customers were told that specimens that meet acceptance criteria, per the product labeling are not affected by the situation and are considered valid results, and that the issue has no impact on results for those runs that generate valid results. Any questions were directed to Abbott Technical Support at 1-800-553-7042, Option 2.

Root cause

Other

Status

Terminated

Product code

MKT

Distribution

Nationwide Distribution

Date initiated

2010-12-20

Date posted

2011-02-23

Date terminated

2012-11-19

Location

Des Plaines, IL