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All product recalls associated with PerkinElmer LAS Inc.
Total Recalls
3
Past Year
0
Class I (Serious)
0
Most Recent
Sep 2004
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component. The kit and IEF gel labels indicate the correct storage temperature of 2-8 degrees C. The product insert incorrectly indicates that the product may be stored at 2-30 degrees C.
There is an increase in the number of normal specimen results below the lowest calibrator and based on a report that the normal controls were running low, sometimes out of the specified range.
Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed.