Recall Z-0688-2013 ยท JLA Conversion To Creatinine, Creatine
Perkinelmer
NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
| 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 | 3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit) |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B Wallac OY, Aug 7, 2008 |