FDA Device recall Z-0686-2013
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030
- FDA Device
- Class II
- terminated
- Published 2013-01-23
On 2013-01-23 the FDA classified a Class II recall of NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030 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-0686-2013 |
| 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
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.
Reason
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Identifiers
| code_info | Lot Numbers: 617341, 619236 |
|---|
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-0686-2013%22
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