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Radiometer America Inc recalls Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of wh
Recalled October 9, 2013 · FDA recall Z-2303-2013 · Radiometer America
Hazard
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. · FDA Class II
Units
13,632 boxes/4 membranes
Sold at
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, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.
Description
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.
Product
Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
Manufacturer(s)
Radiometer America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →