Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor CT/NG NG Detection Kit
FDA device recall Z-1361-04 · 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
- Product code
- LSL
- Quantity affected
- 1747 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
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Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K974503) | Roche Molecular Systems, Inc. | 1999-12-01 |