Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Crea A and B membranes Recalled by Radiometer America Inc Due to Negative drift on QC during in-use lifetime of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Radiometer America Inc directly.
Affected Products
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 the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF), in vitro testing of samples of expired air for the parameters pO2 and pCO2, in vitro testing of pleura samples for the pH parameter.
Quantity: 10,824 boxes
Why Was This Recalled?
Negative drift on QC during in-use lifetime of CREA membranes can be observed.
Where Was This Sold?
This product was distributed to 27 states: CA, CO, CT, FL, GA, IL, IN, KS, ME, MD, MA, MI, MN, MO, NE, NM, NY, NC, OH, OK, PA, TN, TX, VA, WA, WV, WI
About Radiometer America Inc
Radiometer America Inc has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report