FDA Device recall Z-1293-2015

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 s…

FDA Device
Class II
terminated
Published 2015-03-25

On 2015-03-25 the FDA classified a Class II recall of 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 s… by Radiometer America, citing negative drift on QC during in-use lifetime of CREA membranes can be observed.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1293-2015
Classification	Class II
Status	terminated
Initiated	2014-10-29
Published	2015-03-25
Last updated	2026-09-13 11:53 UTC
Company	Radiometer America
Distribution	CA, CO, CT, FL, GA, IL, IN, KS, MA, MD, ME, MI, MN, MO, NC, NE, NM, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV

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 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.

Reason

Negative drift on QC during in-use lifetime of CREA membranes can be observed.

Identifiers

code_info	Model Number 942-073; all lots which have not expired their product lifetime which would be lot 972-073R0465 and onward… 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 94

code_info

Model Number 942-073; all lots which have not expired their product lifetime which would be lot 972-073R0465 and onward…

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 94

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1293-2015%22

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