Reported Apr 29, 2020 · Terminated
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use…
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?
ABL90 FLEX AnalyzerModel Numbers 393-090with software versions below 3.4MR2 -
- Product UsageIt is intended for use in a laboratory environment, near patient or point-of-care setting
- Lot codes and dates
- software versions below 3.4 MR2
- Amount recalled
- 12,822 units
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
The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.
This product could cause temporary or reversible health problems — stop using it.
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