Lactate Membrane units for E7077 Electrode Radiometer Medical ApS — Class II medical device recall Z-2303-2013
Terminated recall by Radiometer America Inc, reported 2013-10-09, distributed nationwide. RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue
| Recall number | Z-2303-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Westlake, OH, United States |
| Recall initiated | 2012-10-08 |
| Classified | 2013-09-30 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2013-12-24 |
| Distributed | Nationwide (US) |
| Model numbers | 942-066, R1741, R1869 |
Product
Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
Reason for recall
RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane.
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-2303-2013. 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.