Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR IC Detection Kit, Export, IVD/CE.

FDA device recall Z-1365-04 · posted 2004-08-19 · Terminated

Recall details

Recalling firm

Roche Molecular Systems Inc

Reason for recall

An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.

Action taken

With respect to U.S distribution, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution center, Roche Diagnostics Corporation of Indianapolis, IN. With respect to overseas distributors, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution centers. Roche stated that the local safety officer is responsible to communicate the advisory both to the customers/end-users and the regulatory authority of the country. On July 6, 2004, a Revised Important Product Advice Notice was sent out to affiliates requiring the immediate discontinuation of the use of the affected kits, and destruction of any kits remaining in customers hands.

Root cause

Other

Status

Terminated

Quantity affected

2425 kits

Distribution

♦ Amplicor CT/NG CT Detection Kit, Lot No.E12231, Material No.20759392018, Expiration 2/2005 , Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. ♦

Date initiated

2004-07-07

Date posted

2004-08-19

Date terminated

2005-01-07

Location

Belleville, NJ