FDA Recall Terminated

DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010

Recall: Z-0689-2013 · Initiated November 26, 2012

Recall

Recall Number
Z-0689-2013
Event Number
63771
Firm
Perkinelmer
FEI Number
3006159931
Status
Terminated
Root Cause
Process control
Initiated
November 26, 2012
Posted
January 16, 2013
Terminated
March 7, 2014
Address
940 Winter Street, Waltham, MA, 02451

Description

DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010

Reason

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.

Distribution

Nationwide Distribution.

Quantity

56 kits (100 plates/kit)