FDA Medical Device Recalls (openFDA)
Radiometer America Inc: D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer.
- Recall number
- Z-1314-06
- Recalling firm
- Radiometer America Inc
- Product
- D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer.
- Status
- Terminated
- Initiated
- 2005-02-01
- Posted
- 2006-08-01
- Terminated
- 2011-11-18
- Reason
- The CI membrane units generate too low values for status and sensitivity during calibration.
- Root cause
- Other
- Action
- The recalling firm sent a letter, dated 2/05, to all of their consignees.The letter instructed the customers to discontinue use of the product and discard any remaining stock which they had on hand. The letter was accompanied by replacement chloride membranes to replace the customer''s portion of the suspect lot.
- Quantity
- 85/4 unit boxes
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot Code: R0053.
- 510(k) numbers
- ["K980130"]
- PMA numbers
- not on file
- Product code
- CGZ
- 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