FDA Device recall Z-0687-2013
NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measuremen…
- FDA Device
- Class II
- terminated
- Published 2013-01-23
On 2013-01-23 the FDA classified a Class II recall of NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measuremen… by Perkinelmer, citing truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0687-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-26 |
| Published | 2013-01-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Perkinelmer |
| Distribution | US |
Product
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.
Reason
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Identifiers
| code_info | Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0687-2013%22
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