Food, drugs, devices › Radiometer America Inc
Device recall: Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of wh
Radiometer America Inc (Westlake, OH) initiated this device recall on 8 Oct 2012; FDA lists 1 product record under event 66108, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 24 Dec 2013. Initiation: voluntary: firm initiated. Radiometer America Inc has 22 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Radiometer America Inc, Westlake, OH.
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."
Distribution
"Nationwide Distribution, including the states of: AK, AL, AR, AZ, BM, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2303-2013 | Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood. | 13,632 boxes/4 membranes | Class II | Terminated | 9 Oct 2013 |
Context
Other enforcement events for Radiometer America Inc
All 22 events for Radiometer America Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution, including the states of: AK, AL, AR, AZ, BM, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Dec 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.