Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
This recall has been terminated (originally issued September 30, 2013).
- Company
- Radiometer America Inc
- Recall Initiated
- October 8, 2012
- Posted
- September 30, 2013
- Terminated
- December 24, 2013
- Recall Number
- Z-2303-2013
- Quantity
- 13,632 boxes/4 membranes
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
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, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.
Lot / Code Info
Part Number: 942-066 R1741 to R1869
Root Cause
Process control
Action Taken
On 11/07/2012, the firm sent "Urgent Field Safety Notices to their customers. The product issue was described and recommended actions were provided. Customers may contact 1 (800) 736-0600, option 4 if questions.