| | Class 2 Recall
Perkin Elmer NEONATAL TOTAL GALACTOSE KIT |  |
| Date Posted |
January 16, 2013 |
| Recall Number |
Z-0688-2013 |
| 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. |
| Code Information |
Lot Numbers: 618201, 619200, 618263
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Recalling Firm/
Manufacturer |
Perkinelmer
940 Winter Street
Waltham, Massachusetts 02451 |
Reason for
Recall |
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
|
| 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 detected in a well of the plate, it is required during use of the well, the volume of solution in the well should be visually confirmed to be consistent before and after incubation.
Please contact PerkinEimer Technical Support for further information (800) 321 -9632, select prompt 2. |
| Quantity in Commerce |
3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit) |
| Distribution |
Nationwide Distribution. |
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