FDA Medical Device Recalls (openFDA)
Radiometer America Inc: ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
- Recall number
- Z-1325-06
- Recalling firm
- Radiometer America Inc
- Product
- ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
- Status
- Terminated
- Initiated
- 2005-10-31
- Posted
- 2006-08-03
- Terminated
- 2012-02-24
- Reason
- ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.
- Root cause
- Other
- Action
- The firm initiated this recall on 10/31/2005, at which time a Field Action Note was issued to their Service Reps. The notice instructed the service personnel to upgrade all ABL800 analyzer units presently running with software version V5.21 to the new version V5.23, in order to correct this problem. The Service Personnel began conducting visits at each customer site on 10/31/2005.
- Quantity
- 36
- Distribution
- Worldwide, including USA and Canada.
- Lot, serial or model codes
- All ABL800 analyzers running software vers 5.21 i.e. ABL8xx 754R00xx N0xx
- 510(k) numbers
- ["K041874"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 1523456
- Firm city
- Westlake
- Firm state
- OH
- 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