Radiometer America Inc: Medical Device Recall in 2013 - (Recall #: Z-2303-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.

Product Classification:

Class II

Date Initiated: October 8, 2012

Date Posted: October 9, 2013

Recall Number: Z-2303-2013

Event ID: 66108

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.

Status: Terminated

Product Quantity: 13,632 boxes/4 membranes

Code Information:

Part Number: 942-066 R1741 to R1869

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated