FDA Devices recall · Reported March 25, 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 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.
Negative drift on QC during in-use lifetime of CREA membranes can be observed.
Radiometer America Inc recalled Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX anal… - a moderate-severity action.
Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX anal… was recalled by Radiometer America Inc in March 25, 2015. Reason: Negative drift on QC during in-use lifetime of CREA membranes can be observed.. Check the official notice for the remedy. Verify recall #Z-1293-2015 with the FDA Devices before acting.
The recall
Radiometer America Inc issued this moderate-severity FDA Devices recall-Negative drift on QC during in-use lifetime of CREA membranes can be observed..
- Moderate
- severity level
- Class II
- classification
- March 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1293-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1293-2015) was formally reported on March 25, 2015, with the manufacturer initiating the action on October 29, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Radiometer America Inc is listed as the recalling firm, operating out of Westlake, OH. Federal records list the affected scope as 10,824 boxes.
The documented reason for this recall is: Negative drift on QC during in-use lifetime of CREA membranes can be observed. Distribution data in the federal record shows the product reached: 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, Ger…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1293-2015 |
| Date reported | March 25, 2015 |
| Date initiated | October 29, 2014 |
| Recalling firm | Radiometer America Inc |
| Firm location | Westlake, OH |
| Affected scope | 10,824 boxes |
| Distribution | 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, Hun… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1293-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Methodology · Corrections · Archive as of August 2026