FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic.
- Recall number
- Z-2178-2011
- Recalling firm
- Beckman Coulter Inc.
- Product
- Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic.
- Status
- Terminated
- Initiated
- 2009-12-17
- Posted
- 2011-05-10
- Terminated
- 2012-03-29
- Reason
- Beckman Coulter has confirmed reports that the Access Free T3 calibrator lot numbers 989902, 989903, 989904, 989905, 989906 and 989907 will show a decline in performance before reaching their stated expiration date. The affected calibrator lots will cause one or more quality control samples to produce out-of-range high result.
- Root cause
- Nonconforming Material/Component
- Action
- Beckman Coulter sent a letter dated December 29, 2009, providing the customers with an explanation of the reason for recall and asked them to take the following actions: - Discontinue use of the lots of reagent listed above. - Review your historical quality control to ensure that the assay performance of these lots has been within your laboratory specifications. NOTE: Out-of-range high quality control results may indicate invalid test results. Consignees were asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation; and complete and return the enclosed response form within 10 days so that Beckman can be assured that they received this important notification. Assistance or questions regarding this notification, were directed to Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact consignees were told to contact their local Beckman Coulter Representative.
- Quantity
- 2,320 kits
- Distribution
- Distribution Nationwide and Canada.
- Lot, serial or model codes
- Lot #'s: 989902, 989903, 989904, 989905, 989906 & 989907
- 510(k) numbers
- ["K042651"]
- PMA numbers
- not on file
- Product code
- JIT
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- 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