FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer)
- Recall number
- Z-0315-2008
- Recalling firm
- Beckman Coulter Inc
- Product
- COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer)
- Status
- Terminated
- Initiated
- 2007-04-18
- Posted
- 2007-12-22
- Terminated
- 2012-04-16
- Reason
- Patient Mis-identification can occur: 1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2)- When manually entering a Patient ID, if a blank space is entered between th
- Root cause
- Software design
- Action
- Product Corrective Action (PCA) letters were mailed on April 18,2007, to all GENS, LH500, LH750 and LH780 accounts. They are informed that a potential misidentification can occur in 2 scenarios. 1. When a positive identifier (Sample ID or CassetteIPosition) is manually edited to a positive identifier that is already in the ToDo list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2. When manually entering a Patient ID, if a blank space is entered between the characters in the Patient ID field, the system will only accept the characters before the space.----Short term fix----- The letter explains the issues and provides the customer work around. (Letters were sent by US mail). A customer response form was provided. The root cause of the problem is still under investigation, software upgrades, when approved will be made to devices.
- Quantity
- 815 units to the US; 95 units to Canada
- Distribution
- World wide: USA and Canada
- Lot, serial or model codes
- Part Number 6605381. All software versions
- 510(k) numbers
- ["K962988"]
- PMA numbers
- not on file
- Product code
- GKL
- 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
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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