| Class 2 Device Recall | |
Date Initiated by Firm | July 07, 2004 |
Date Posted | August 19, 2004 |
Recall Status1 |
Terminated 3 on January 07, 2005 |
Recall Number | Z-1368-04 |
Recall Event ID |
29566 |
Product Classification |
Dna-Reagents, Neisseria - Product Code LSL
|
Product | Amplicor [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 Contact | Karen 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 |
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. |
Quantity in Commerce | 559 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 Cycle | TPLC Device Report |
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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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