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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number 942-073; all lots which have not expired their product lifetime which would be lot 972-073R0465 and onward: Affected lot numbers 942-073R0465 942-073R0468 942-073R0469 942-073R0470 942-073R0471 942-073R0472 942-073R0474 942-073R0475 942-073R0476 942-073R0478 942-073R0479 942-073R0480 942-073R0481 942-073R0482 942-073R0487 942-073R0488 942-073R0489 942-073R0490 942-073R0491 942-073R0492 942-073R0493 942-073R0494 942-073R0495 942-073R0496 942-073R0497 942-073R0498 942-073R0499 942-073R0500 942-073R0501 942-073R0502 942-073R0503 942-073R0504 942-073R0507 942-073R0509 942-073R0510 942-073R0511 942-073R0512 942-073R0513 942-073R0515 942-073R0518 942-073R0520 942-073R0521 942-073R0522 942-073R0523 942-073R0524 942-073R0525 942-073R0526 942-073R0527 942-073R0528 942-073R0529 942-073R0530 942-073R0532 942-073R0533 942-073R0534 942-073R0535 942-073R0536 942-073R0537 942-073R0538 942-073R0539 942-073R0540 942-073R0541 942-073R0542 942-073R0544 942-073R0545 942-073R0546 942-073R0548 942-073R0549 942-073R0550 942-073R0551 942-073R0553 942-073R0555 942-073R0556 942-073R0557 942-073R0558 942-073R0560 942-073R0561 942-073R0562 942-073R0564 942-073R0565 942-073R0566 942-073R0567 942-073R0569 And onwards: The firm is still determining the scope of how many lot numbers are affected.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Radiometer America Inc
- Reason for Recall:
- Negative drift on QC during in-use lifetime of CREA membranes can be observed.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Model Number 942-073; all lots which have not expired their product lifetime which would be lot 972-073R0465 and onward: Affected lot numbers 942-073R0465 942-073R0468 942-073R0469 942-073R0470 942-073R0471 942-073R0472 942-073R0474 942-073R0475 942-073R0476 942-073R0478 942-073R0479 942-073R0480 942-073R0481 942-073R0482 942-073R0487 942-073R0488 942-073R0489 942-073R0490 942-073R0491 942-073R0492 942-073R0493 942-073R0494 942-073R0495 942-073R0496 942-073R0497 942-073R0498 942-073R0499 942-073R0500 942-073R0501 942-073R0502 942-073R0503 942-073R0504 942-073R0507 942-073R0509 942-073R0510 942-073R0511 942-073R0512 942-073R0513 942-073R0515 942-073R0518 942-073R0520 942-073R0521 942-073R0522 942-073R0523 942-073R0524 942-073R0525 942-073R0526 942-073R0527 942-073R0528 942-073R0529 942-073R0530 942-073R0532 942-073R0533 942-073R0534 942-073R0535 942-073R0536 942-073R0537 942-073R0538 942-073R0539 942-073R0540 942-073R0541 942-073R0542 942-073R0544 942-073R0545 942-073R0546 942-073R0548 942-073R0549 942-073R0550 942-073R0551 942-073R0553 942-073R0555 942-073R0556 942-073R0557 942-073R0558 942-073R0560 942-073R0561 942-073R0562 942-073R0564 942-073R0565 942-073R0566 942-073R0567 942-073R0569 And onwards: The firm is still determining the scope of how many lot numbers are affected.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1293-2015
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