FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
- Recall number
- Z-0002-2008
- Recalling firm
- Beckman Coulter Inc
- Product
- FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
- Status
- Terminated
- Initiated
- 2007-02-22
- Posted
- 2007-10-16
- Terminated
- 2012-04-26
- Reason
- Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.
- Root cause
- Labeling design
- Action
- A Product Corrective Action (PCA) letter was mailed on Feb 22, 2007, to all FP1000 customers to inform them of an issue associated with the FP1000 Cell Preparation System. Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented. Under these conditions the FP1000 will under-dispense specimen volume leading to lower than expected absolute counts. Specimen tubes that are recapped or underfilled must therefore be vented prior to running on the FP1000. If the initial state of the specimen tube is unknown, then it must be vented to ensure accurate results prior to running on the FP1000. Additional instructions are provided. A Fax Back Response Form was also provided.
- Quantity
- 9 in the U.S.; 1 in Canada
- Distribution
- Nationwide (MA, IN, IL, UT, RI, NJ), and Canada.
- Lot, serial or model codes
- Part Number 624922. Software versions 1.1 & 1.2
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXG
- 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