Recall Z-0686-2013 ยท JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Perkinelmer
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 a
| Date | Jan 16, 2013 (initiated Nov 26, 2012) |
| Status | Terminated |
| Reason | Truncated V-Bottomed Microplate Wells used in assays contain defective wells. |
| Root cause | Process control |
| Action | Perkin Elmer initiated the recall on November 23, 2012. The Recall Letter will be delivered to the end customer by email facilitated through our PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and implement the recommended precautions: - Inspect the wells of row A and row H of the affected microplate lots for possible holes and cracks prior to use. - If a hole or crack is visually detected in a well of the microplate, the well should not be used for testing. - If a hole or crack is not visually d |
| Quantity | 180 kits (20 plates/kit) |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021541 | NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT Perkinelmer Life Sciences, Oct 28, 2002 |