Reported Jul 13, 2022 · Ongoing
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
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 · N/A
Is this the product you have?
- ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
- Lot codes and dates
- All ABL800 Flex Analyzers containing software versions below V6.19 MR2; UDI/DI ABL810, 820, and 830, ABL805, ABL815, ABL825
- ABL835
05700693938004UDI/DI ABL817ABL827
- ABL83705700693938011
- Amount recalled
- 1489 analyzers
Where it was sold
Why it was recalled
There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
This product could cause temporary or reversible health problems — stop using it.
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