Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers wh...
FDA Device Recall #Z-1293-2015 — Class II — October 29, 2014
Recall Summary
| Recall Number | Z-1293-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 29, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Radiometer America Inc |
| Location | Westlake, OH |
| Product Type | Devices |
| Quantity | 10,824 boxes |
Product 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.
Reason for Recall
Negative drift on QC during in-use lifetime of CREA membranes can be observed.
Distribution Pattern
Worldwide Distribution - USA including NM, NC, TN, OH, NE, CA, MO, GA, MA, TX, WV, PA, NY, VA, MN, IN, ME, MD, IL, MI, KS, WI, FL, WA, CT, OK, CO, and Internationally to Canada, Denmark, Spain, Italy, India, Sweden, Germany, Australia, Hungary, Great Britain, Norway, Uruguay, France, Poland, Switerland, Russian Federation, Netherlands, Czech Republic, Mexico, Brazil, Czechoslovakia, Austria, Singapore, Syria, Phillipines, Egypt, Bolivia, Japan, New Zealand, Turkey, Saudi Arabia, Algeria, Qatar, and Finland.
Lot / Code Information
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.
Other Recalls from Radiometer America Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2320-2019 | Class II | ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 | Jul 10, 2019 |
| Z-0682-2019 | Class II | ABL800 analyzer, model numbers 393-800 and 393-... | Jul 3, 2018 |
| Z-0801-2019 | Class II | Product: ABL800 FLEX with Crea. The ABL800 with... | Jul 2, 2018 |
| Z-0010-2019 | Class II | ABL90 FLEX analyzers with software versions 3.3... | May 25, 2018 |
| Z-0231-2018 | Class II | ABL800 analyzer with FLEXQ module. Device in... | Oct 24, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.