Reported Jun 23, 2021 · Ongoing
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Radiometer Medical ApS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Radiometer Medical ApS · Akandevej 21 · Bronshoj · N/A
Is this the product you have?
- Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
- Lot codes and dates
- Model NumberABL90
- FLEX PLUS (393-092) Serial NumbersABL90 FLEX PLUS analyzers serial numbers R0214 R0218, and R0223 onwards
- Amount recalled
- Total=4,135 analyzers world-wide (only 1277 analyzers within the U.S.)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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