Crea A and B membranes — Class II medical device recall Z-1293-2015
Terminated recall by Radiometer America Inc, reported 2015-03-25, distributed in CA, CO, CT, FL, GA, IL, IN, KS…. Negative drift on QC during in-use lifetime of CREA membranes can be observed.
| Recall number | Z-1293-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Westlake, OH, United States |
| Recall initiated | 2014-10-29 |
| Classified | 2015-03-18 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2015-07-02 |
| Distributed | 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 |
| Countries outside the US | AT, AU, BO, BR, CA, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, HU, IN, IT, JP, MX, NL, NO, NZ, PL, QA, SA, SE, SG, TR, UY |
| Quantity | 10,824 boxes |
| 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 and 43 more |
| Model numbers | 942-073 |
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 for recall
Negative drift on QC during in-use lifetime of CREA membranes can be observed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1293-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.