Enforcement Report - Week of October 3, 2012
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Event Detail
| Event ID | 62440 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| City | Jamestown |
| State | NY |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-29 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera. | Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568 | Class III | The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range. | 810 kits | Z-2445-2012 |
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