NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U — Class II medical device recall Z-0687-2013
Terminated recall by Perkinelmer, reported 2013-01-23, distributed nationwide. Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
| Recall number | Z-0687-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perkinelmer, Waltham, MA, United States |
| Recall initiated | 2012-11-26 |
| Classified | 2013-01-16 |
| Reported by FDA | 2013-01-23 |
| Terminated | 2014-03-07 |
| Distributed | Nationwide (US) |
| Lot numbers | 617253, 617346, 618494, 618653, 618764, 619453 |
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 for recall
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0687-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.