Terminated

Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor CT/NG NG Detection Kit

FDA Recall Z-1361-04 · Posted 2004-08-19

Recalling FirmRoche Molecular Systems Inc

Recall StatusTerminated

Product CodeLSL

Date Initiated2004-07-07

Date Terminated2005-01-07

Product Quantity1747 kits

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.

Firm Action

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

Distribution Pattern

♦ 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. ♦ Amplicor CT/NG NG Detection Kit, Lot No.E12647, Material No.20759406018, Expiration 2/2005, Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. ♦ Amplicor HCV Detection Kit, v2.0, Lot No.F01023, Material No.21118439018, Expiration 5/2005, Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. ♦ Amplicor IC Detection Kit, 96 tests, Lot No.E09554, Material No.20751952018, Expiration 5/2005, Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. Export-U.S Distributed Products: AmpliCap HCV Monitor Test, Lot No.E09193, Material No.21111337018, Expiration 8/2004 , Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan. Amplicor IC Detection Kit, Lot No.E13115, Material No.20763306122, Expiration 7/2005, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan; Shipped To: Roche Diagnostics Canada, 201 Boulevard Armand-Frappier, Laval QC H7V 4A2, Canada; Shipped To: Roche Diagnostics GmbH, GX-OSW, Sandhoferstr. 116, D-68305 Mannheim. Amplicor M. avium Detection Kit, Lot No.E12990, Material No.20759880018, Expiration 11/2004, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan. Amplicor MTB Detection Kit, Lot No.E13307, Material No.20757462122, Expiration 9/2004, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan; Shipped To: Roche Diagnostics Canada, 201 Boulevard Armand-Frappier, Laval QC H7V 4A2, Canada Shipped To: Roche Diagnostics GmbH, GX-OSW, Sandhoferstr. 116, D-68305 Mannheim. Amplicor NG Detection Kit, Lot No.E10894, Material No.20744026122, Expiration 2/2005, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan ; Shipped To: Roche Diagnostics Canada, 201 Boulevard Armand-Frappier, Laval QC H7V 4A2, Canada; Shipped To: Roche Diagnostics GmbH, GX-OSW, Sandhoferstr. 116, D-68305 Mannheim. There are no Govt. accounts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974503ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAERoche Molecular Systems, Inc. · 1999-12-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.