FDA Medical Device Recalls (openFDA)
Radiometer America Inc: ABL800 analyzer, model numbers 393-800 and 393-801.
- Recall number
- Z-0682-2019
- Recalling firm
- Radiometer America Inc
- Product
- ABL800 analyzer, model numbers 393-800 and 393-801.
- Status
- Terminated
- Initiated
- 2018-07-03
- Posted
- not on file
- Terminated
- 2023-08-30
- Reason
- The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
- Root cause
- Software design
- Action
- The recalling firm issued letters dated 7/3/2018 on 7/3/2018 via FedEx.
- Quantity
- 2,131 analyzers
- Distribution
- Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.
- Lot, serial or model codes
- Model 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835. Model 393-801 ABL800 Series with Creatinin (All serial numbers) for the following configurations: ABL817, ABL827, and ABL837.
- 510(k) numbers
- ["K041874"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 3010420736
- Firm city
- Brea
- 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