Enforcement Report - Week of March 20, 2013
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Product Detail
| Product Description | ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease. |
|---|---|
| Recall Number | Z-0927-2013 |
| Classification | Class II |
| Code Info | Lot #120960 (121003. 121058,121002), ; Exp./Cad/Verw/bis: 2013-09; Catalog#802-3011; 25271, 25272, 25273; Label P/N 522-0040, 522-0037, 522-0011 |
| Product Distributed Qty | 195 |
| Reason For Recall | Multiple incidents of low-reacting assay plates. |
Event Detail
| Event Id | 64348 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Innominata Dba Genbio |
| City | San Diego |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-02-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI. |
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