FDA Medical Device Recalls (openFDA)
Perkinelmer: DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
- Recall number
- Z-0689-2013
- Recalling firm
- Perkinelmer
- Product
- DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
- Status
- Terminated
- Initiated
- 2012-11-26
- Posted
- 2013-01-16
- Terminated
- 2014-03-07
- Reason
- Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
- Root cause
- 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.
- Quantity
- 56 kits (100 plates/kit)
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot Numbers: 618609
- 510(k) numbers
- ["K071649"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3006159931
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28