Reported Mar 25, 2015 · Terminated

Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for:…

Radiometer America Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Radiometer America Inc · 810 Sharon Dr · Westlake, OH · 44145-1521

Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800
FLEX analyzers which are intended forIn 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

Lot codes and dates: Model Number 942-073; all lots which have not expired their product lifetime which
would be lot 972-073R0465 and onwardAffected lot numbers
82 of 82 codes
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
And onwardsThe firm is still determining the scope of how many lot numbers are affected
Amount recalled: 10,824 boxes

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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