Recall Z-0690-2013
Perkinelmer · initiated November 26, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.
Codes / lots: Lot Numbers: 616792 , 617141 , 617980 , 618319, 618664, 618831, 619175
Reason for recall
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0690-2013
- Initiated
- November 26, 2012
- Posted by FDA
- January 16, 2013
- Terminated
- March 7, 2014
- Distribution
- Nationwide Distribution.
- Recalling firm
- Perkinelmer, Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0686-2013 Class II | NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number:…Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | 11/26/2012Terminated |
| Z-0687-2013 Class II | NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass…Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | 11/26/2012Terminated |
| Z-0688-2013 Class II | NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended…Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | 11/26/2012Terminated |
| Z-0689-2013 Class II | DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | 11/26/2012Terminated |