FDA Medical Device Recalls (openFDA)
Radiometer America Inc: ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27
- Recall number
- Z-0705-2007
- Recalling firm
- Radiometer America Inc
- Product
- ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27
- Status
- Terminated
- Initiated
- 2007-01-16
- Posted
- 2007-04-06
- Terminated
- 2012-05-08
- Reason
- In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.
- Root cause
- Other
- Action
- Radiometer America issued a recall letter to their U.S. customers dated 1/16/2007. The letter informs the customers of this software anomaly and the conditions underwhich analyzer results can be stored with incorrect Patient Demographics. The letter goes on to inform the customers that a Radiometer Service Representative will be visiting each customer location shortly in order to upgrade the affected software. In the meantime, the letter recommends that the customer(s) not pre-register their samples. The letter is accompanied by an attached FAX FORM which the customer is asked to sign and complete in order to verify receipt of the recall letter and to fax back to the recalling firm.
- Quantity
- 64 in U.S. & 1,281 to foreign accounts
- Distribution
- Worldwide Distribution-USA including states of NY, KS, SD, OH, TX, KY, NC, IL, MO, AL, UT, CO, CA, NM, and MI and Country of Denmark
- Lot, serial or model codes
- There are no specific lot codes. (devices equipped with software version 5.2 to 5.27)
- 510(k) numbers
- ["K043218"]
- 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