FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Code: JIS The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems.
- Recall number
- Z-3027-2011
- Recalling firm
- Beckman Coulter Inc.
- Product
- Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Code: JIS The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems.
- Status
- Terminated
- Initiated
- 2010-08-26
- Posted
- 2011-08-16
- Terminated
- 2012-07-11
- Reason
- The recall was initiated because Beckman Coulter has confirmed that the stability claims for the Access Total T4 calibrators may not be met. This issue is associated with calibrator lots 917074 and 008534.
- Root cause
- Nonconforming Material/Component
- Action
- Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated September 13, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the affected lot numbers and review historical quality control performance. Additionally, a response form was attached to the letter for customers to complete and return. Alternate lots will be provided for current and future replenishment orders or requests. Customers with questions regarding this notification can call Technical Support at (800) 854-3633 or contact their local Beckman Coulter representative.
- Quantity
- 2495 units total (2492 in US)
- Distribution
- Worldwide Distribution-USA (nationwide) and the country of Canada.
- Lot, serial or model codes
- Lot Number: 917074, 008534 Expiration Date: 917074 (12/31/10), 008534 (2/28/11)
- 510(k) numbers
- ["K023369"]
- PMA numbers
- not on file
- Product code
- KLI
- 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