Enforcement Report - Week of January 23, 2013
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Product Detail
| Product Description | NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders. |
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| Recall Number | Z-0687-2013 |
| Classification | Class II |
| Code Info | Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453 |
| Product Distributed Qty | 819 kits (10 plates/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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