Recall Z-2171-2013 ยท CGN Acid, Folic, Radioimmunoassay
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
| Date | Sep 10, 2013 (initiated Jul 25, 2013) |
| Status | Terminated |
| Reason | Calibration failures and/or significant negative shifts in quality control (QC) and patient results. |
| Root cause | Material/Component Contamination |
| Action | Siemens sent an Urgent Medical Device Correction letter on July 26, 2013, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. an Urgent Field Safety Notice was sent to all domestic customers via Federal Express. On July 25, 2013 this notice was sent to all OUS customers via hard copy, email, and/or fax as determined by each country's local regulations and procedures. These notices inform the customer that a portion of Folate ReadyPacks in kit lots ending in 218 are exhibiting calibration failures and/o |
| Quantity | 488 |
| Distribution | Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010050 | ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY Bayer Diagnostics Corp., Feb 5, 2001 |