Recall Z-1075-2014 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.
| Date | Feb 24, 2014 (initiated Jul 5, 2013) |
| Status | Terminated |
| Reason | RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results. |
| Root cause | Under Investigation by firm |
| Action | On 7/18/2013, the firm sent Product Notification letters to their customers. |
| Quantity | 38,890 units (7,860 units imported into the US) |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, 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, VT, WA, WI, WV & WY, and the countries of Bermuda an |
| FDA record | Open on fda.gov |