Enforcement Report - Week of January 23, 2013
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Product Detail
| Product Description | NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia. |
|---|---|
| Recall Number | Z-0688-2013 |
| Classification | Class II |
| Code Info | Lot Numbers: 618201, 619200, 618263 |
| Product Distributed Qty | 3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit) |
| Reason For Recall | Truncated V-Bottomed Microplate Wells used in assays contain defective wells. |
Event Detail
| Event Id | 63771 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Perkinelmer |
| City | Waltham |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-26 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Nationwide Distribution. |
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