Recall Z-0687-2013 ยท NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Perkinelmer
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
| 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 | 819 kits (10 plates/kit) |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083130 | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 Perkinelmer, Inc., Jul 9, 2009 |