Device product
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.
Z-0688-2013
Product summary
- Firm
- Perkinelmer
- Event
- Event 63771
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit)
- Official record key
device-enforcement:Z-0688-2013
Official wording
Reason: Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Code information: Lot Numbers: 618201, 619200, 618263
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.