FDA Medical Device Recalls (openFDA)
Sendx Medical Inc: ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863
- Recall number
- Z-1201-2007
- Recalling firm
- Sendx Medical Inc
- Product
- ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863
- Status
- Terminated
- Initiated
- 2007-06-04
- Posted
- 2007-08-29
- Terminated
- 2012-02-29
- Reason
- The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. Elevated hemoglobin concentrations have the greatest impact on this calculation err
- Root cause
- Other
- Action
- A total of eight (8) distributors and the Radiometer main office in Denmark were sent the recall package (Field Action Notice) by email on 6-6-07. The distributors were provided background information and specific instruction on the steps to perform to correct the problem. The Recall package included a Management Cover for Field Action Notes and the Field Action Notice. Radiometer has released a subsequent software upgrade (v.1.11) to correct the two problems noted in the Recall Notice.
- Quantity
- 165 software upgrade CDs
- Distribution
- In US to Cleveland, OH and Worldwide to Belgium, Denmark, France, Germany, The Netherlands, Sweden & United Kingdom
- Lot, serial or model codes
- Software Version 1.10 Lot numbers: 17293, 17384, 17440, 17515, 17572 and 17663.
- 510(k) numbers
- ["K051804"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 2027541
- Firm city
- Carlsbad
- 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
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