FDA Medical Device Recalls (openFDA)
Abbott Laboratories: CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.
- Recall number
- Z-0565-2007
- Recalling firm
- Abbott Laboratories
- Product
- CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.
- Status
- Terminated
- Initiated
- 2006-12-22
- Posted
- 2007-03-01
- Terminated
- 2007-11-28
- Reason
- Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.
- Root cause
- Other
- Action
- Recall initated 12/22/2006. Product letters were sent to consignees, as well as a customer reply form. The letters were sent with customer reply forms. Responses will be tracked via the response forms included with letters.
- Quantity
- 652 (20 L. each) cubitainers
- Distribution
- Nationwide, including California and Nevada. An Abbott Laboratories facility in Hong Kong.
- Lot, serial or model codes
- Lot Number 42063I2, List Number 01H73-01
- 510(k) numbers
- ["K051215","K061667","K961439"]
- PMA numbers
- not on file
- Product code
- GIF
- 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