FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Coulter Clone B6-FITC Reagent
- Recall number
- Z-1071-03
- Recalling firm
- Beckman Coulter Inc
- Product
- Coulter Clone B6-FITC Reagent
- Status
- Terminated
- Initiated
- 2003-04-28
- Posted
- 2003-07-30
- Terminated
- 2004-04-20
- Reason
- Diminished expression on B-Cell populations when drawn in EDTA tubes, which may lead to inaccurate interpretation of phenotype results. It was determined that choice of anticoagulant may have an effect on results for this reagent. The CD23 clone has shown a diminished expression on B-Cell populations when drawn on EDTA tubes, which may lead to inaccurate interpretation of phenotype results.
- Root cause
- Other
- Action
- Customer letters will be sent to all known purchasers on or about 4/28/2003, also existing inventory will be reworked to include a letter describing performance issues when collection occurs using EDTA.
- Quantity
- 122
- Distribution
- Nationwide and to Canada
- Lot, serial or model codes
- Lots 735512F, 735513F and 735514FR
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- 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