Device 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.
Z-0686-2013
Product summary
- Firm
- Perkinelmer
- Event
- Event 63771
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 kits (20 plates/kit)
- Official record key
device-enforcement:Z-0686-2013
Official wording
Reason: Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Code information: Lot Numbers: 617341, 619236
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.