The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitativ

FDA device recall Z-2398-2012 · posted 2012-09-17 · Terminated

Recall details

Recalling firm

Bio-Rad Laboratories

Reason for recall

Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.

Action taken

The firm, Bio-Rad Laboratories, Inc., sent an "Important Product Information Bio-Rad MONOLISA Anti-HBs EIA Catalog #25220", letter dated 27 July 2012, to their domestic consignees/customers via FedEx. The International subsidiaries will be notified by e-mail. The consignees/customers were informed of the important storage and handling information regarding the MONOLISA Anti-HBs EIA Conjugate Diluent component . The consignees/customers were instructed to follow the storage and handling instructions as stated in the Package Insert, and compare their laboratories practices to the storage and handling instructions stated by Bio-Rad. Customers who have questions can call Bio Rad Technical Support at 1-800-224-6723, option 2, then option 3.

Root cause

Packaging

Status

Terminated

Product code

LOM

Quantity affected

7,400 (approximately)- All lots since distribution date May 9, 2007

Distribution

Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.

Date initiated

2012-07-27

Date posted

2012-09-17

Date terminated

2012-12-14

Location

Redmond, WA