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All product recalls associated with Perkin Elmer.
Total Recalls
11
Past Year
0
Class I (Serious)
0
Most Recent
Jan 2009
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.
If Result Codes are used and if they are manually edited, they are correct unless the laboratory specifically uses the View Assay button in the Specimen History screen to open another assay, and then returns back to the original assay
If Result Codes are used and if they are manually edited, they are correct unless the laboratory specifically uses the View Assay button in the Specimen History screen to open another assay, and then returns back to the original assay
Pump failure may effect data integrity
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.
The device is not stable throughout its labeled expiration date.
Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
Product's outer carton label was labeled with an extended expiration date
The kits are producing lower values than expected, which may result in an increase of false positive test results.
The device is not stable throughout its labeled expiration date.