Recall Z-2303-2013 ยท KHP Acid, Lactic, Enzymatic Method
Radiometer America Inc
Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
| Date | Sep 30, 2013 (initiated Oct 8, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 13,632 boxes/4 membranes |
| 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. |
| FDA record | Open on fda.gov |