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U.S. Department of Health and Human Services

Class 2 Device Recall Perkin Elmer Microplate

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 Class 2 Recall
Perkin Elmer Microplate
see related information
Date Posted January 16, 2013
Recall Status1 Terminated on March 07, 2014
Recall Number Z-0690-2013
Recall Event ID 63771
Premarket Notification
510(K) Numbers
K021541  K071649  K083130 
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.
Code Information Lot Numbers: 616792 , 617141 , 617980 , 618319, 618664, 618831, 619175
Recalling Firm/
Manufacturer
Perkinelmer
940 Winter Street
Waltham, Massachusetts 02451
Manufacturer Reason
for Recall
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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.
Distribution Nationwide Distribution.

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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