Radiometer Crea A and B Membranes Recalled for Negative QC Drift
Radiometer America Inc. is recalling Crea A and B membranes used with ABL800 FLEX analyzers due to negative drift on quality control during their in-use lifetime.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential inaccuracy in test results due to QC drift, which is a significant quality issue but does not involve reported injuries, deaths, or high-risk pathogens, fitting the criteria for a moderate severity score.
Plain-English summary
Radiometer America Inc. is recalling Crea A and B membranes, packaged 4 per box, which are used in conjunction with ABL800 FLEX analyzers. These membranes are intended for in vitro testing of whole blood samples for various parameters, including pCO2, electrolytes, glucose, lactate, creatinine, and co-oximetry parameters.
The recall is being conducted because negative drift on quality control (QC) during the in-use lifetime of the CREA membranes can be observed. This issue may affect the accuracy of the testing results. The affected product is Model Number 942-073, specifically lots 942-073R0465 and onward that have not expired their product lifetime. The firm is still determining the full scope of how many lot numbers are affected.
The recall involves 10,824 boxes distributed worldwide, including the United States and numerous international locations. Users of these products should stop using the affected membranes and contact Radiometer America Inc. for further instructions or replacement.
The recalled product
- Product
- Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and…
- Manufacturer
- Radiometer America Inc
- Hazard
- Affected units
- 10,824
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)
- Model Number 942-073
Distribution
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