Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA 25220; MONOLISA TM Anti-HBs Calibra

FDA device recall Z-1620-2010 · posted 2010-05-20 · Terminated

Recall details

Recalling firm

Bio-Rad Laboratories

Reason for recall

The package insert provided with this kit contains a typographical error, giving incorrect directions to prepare a Working Conjugate Solution. If these directions are followed, it would result in a 1:6 dilution and invalidate the assay.

Action taken

All domestic customers were notified via an Urgent Product Correction customer letter sent by DHL or FedEx on 8/11/08. Enclosed with the letter was a corrected package insert. The Canadian subsidiary was notified via e-mail on 8/11/08. The letter advised customers of the correct wording, and advised that a new corrected package insert was enclosed and to make note of the correction in the laboratory procedures. Questions should be directed to Bio-Rad Laboratories Technical Support at 1-800-224-6723.

Root cause

Packaging process control

Status

Terminated

Product code

LOM

Quantity affected

795 kits

Distribution

Worldwide Distribution -- USA and Canada.

Date initiated

2008-08-11

Date posted

2010-05-20

Date terminated

2010-05-20

Location

Redmond, WA