The Recall Desk
HighFDA (Devices)·Z-1684-2020·Announced 2020-04-15

Radiometer ABL800 FLEX Blood Gas Analyzer Barcode Reader Recall

Radiometer Medical ApS is recalling ABL800 FLEX analyzers because the barcode reader may misinterpret labels, potentially causing patient mixups or sample loss.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (patient mixup or delayed treatment) where specific injuries or illnesses have not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Radiometer Medical ApS is recalling 3,656 units of the ABL800 FLEX blood gas analyzer (model number/UDI 393-800/0570 and 393-801/0570). The recall affects software versions below 6.19. These devices are used for in vitro testing of whole blood, expired air, and pleura samples.

The recall is due to a defect in the analyzer's barcode reader, which may misinterpret the contents of barcode labels used for entering patient ID or accession numbers. This issue is related to barcode types that do not use a check digit. The misinterpretation could result in patient mixup or loss of samples, which may lead to delayed medical treatment.

The affected units were distributed worldwide, including nationwide distribution in the United States and in various countries in Europe, Asia, Africa, and Oceania. Users should contact Radiometer Medical ApS for instructions on how to address the software issue.

The recalled product

Product
ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In
Manufacturer
Radiometer Medical ApS
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
3,656

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software versions below 6.19

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

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