FDA Medical Device Recalls (openFDA)
Abbott Laboratories: Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01
- Recall number
- Z-0648-03
- Recalling firm
- Abbott Laboratories
- Product
- Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01
- Status
- Terminated
- Initiated
- 2002-10-16
- Posted
- 2003-03-13
- Terminated
- 2003-08-21
- Reason
- Product elicits fluorescent signal interference due to contamination.
- Root cause
- Other
- Action
- On 10/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.
- Quantity
- 1383 units
- Distribution
- Nationwide and Argentina, Canada and Puerto Rico.
- Lot, serial or model codes
- Product Control/Lot # 9274912, (Exp. Date: 8/31/2003) Product Control/Lot # 9275012, (Exp. Date: 8/31/2003) Product Control/Lot # 9275212, (Exp. Date: 8/31/2003)
- 510(k) numbers
- ["K961439","K971152","K981342","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