FDA Medical Device Recalls (openFDA)
Radiometer America Inc: Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series.
- Recall number
- Z-1317-06
- Recalling firm
- Radiometer America Inc
- Product
- Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series.
- Status
- Terminated
- Initiated
- 2005-06-17
- Posted
- 2006-08-02
- Terminated
- 2012-02-24
- Reason
- Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.
- Root cause
- Other
- Action
- The customers were apprised of this situation with a recall letter issued by the firm on 6/17/2005. In addition, new Operators Manuals were sent to the customers. In the letter, the customers were advised that a Service Engineer would be contacting them shortly in order to arrange for the installation of the software upgrade. The firm''s Service Engineers visited each customer location and installed software upgrades. Version 3.831 software was installed on the 700 Series Analyzers and Version 4.14 was installed on the 800 Series Analyzers. According to the firm, these software corrections were verified as having been completed by 3/10/2006.
- Quantity
- 1635 devices
- Distribution
- Nationwide.
- Lot, serial or model codes
- All analyzers manufactured from 1/1999-12/2005. The devices contain serial numbers 902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx number denotes the individual instrument within the run.
- 510(k) numbers
- ["K002290","K991417","K992859"]
- 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