FDA Medical Device Recalls (openFDA)
Abbott Laboratories: CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
- Recall number
- Z-0527-06
- Recalling firm
- Abbott Laboratories
- Product
- CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
- Status
- Terminated
- Initiated
- 2005-12-16
- Posted
- 2006-02-16
- Terminated
- 2006-04-13
- Reason
- T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.
- Root cause
- Other
- Action
- The firm has sent notification letters dated Dec. 16, 2005 to all consignees requesting discontinuing of use, destruction of CD3/4/8 reagent if the lab does not plan to run on a CELL-DYN 4000 system.
- Quantity
- 871 units
- Distribution
- Nationwide and Canada, Venezuela, Germany, Hong Kong, Japan, Mexico and Singapore.
- Lot, serial or model codes
- List Number: 07H22-01, lot numbers: 16328 and 29401
- 510(k) numbers
- ["K010953"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 2919069
- Firm city
- Santa Clara
- 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