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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJuly 07, 2004
Date PostedAugust 19, 2004
Recall Status1 Terminated 3 on January 07, 2005
Recall NumberZ-1368-04
Recall Event ID 29566
Product Classification Dna-Reagents, Neisseria - Product Code LSL
ProductAmplicor [3] AV-HRP, Avidin-HRP Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR NG Detection Kit, Export IVD/CE.
Code Information Amplicor [3] AV-HRP, Lot No. E09569 found in kit lot:  Lot E10894, Material #20744026122 Exp. 2/2005.
Recalling Firm/
Manufacturer
Roche Molecular Systems Inc
11 Franklin Ave
Belleville NJ 07109-3501
For Additional Information ContactKaren McCullough
908-253-7610
Manufacturer 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.
FDA Determined
Cause 2
Other
ActionWith 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.
Quantity in Commerce559 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. ♦ 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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