Radiometer America Inc recalls ABL800 analyzer, model numbers 393-800 and 393-801.
- Recall date
- July 3, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0682-2019
- FDA classification
- Class II
- Brand / firm
- Radiometer America Inc
- Sold / distributed
- Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.
Why it was recalled
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ABL800 analyzer, model numbers 393-800 and 393-801.
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