FDA Medical Device Recalls (openFDA)
Radiometer America Inc: Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box.
- Recall number
- Z-1323-06
- Recalling firm
- Radiometer America Inc
- Product
- Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box.
- Status
- Terminated
- Initiated
- 2005-09-19
- Posted
- 2006-08-03
- Terminated
- 2012-02-24
- Reason
- Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument.
- Root cause
- Other
- Action
- Following the receipt of three (3) customer complaints, on 9/14/2005, the firm issued an E-Mail notification [Management Cover] to their Service Personnel on 9/19/2005. The Management Cover instructed the service personnel to check the electrodes located at their stock and their customer locations; put all electrodes, which cannot be inserted in their call-back stock; and provide for credit to their customers through normal channels. The Service Personnel in turn, contacted their customers via telephone on or around 9/20/2005 and asked that they check their inventories for the presence of any electrodes which would not fit in the analyzer and return any such electrodes to Radiometer America for replacement
- Quantity
- 34
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- Part #945-603 - Lot #96-01 and #96-02
- 510(k) numbers
- ["K980130"]
- 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