Recall Z-1970-2013 ยท JIS Calibrator, Primary
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.
| Date | Aug 14, 2013 (initiated Jun 28, 2013) |
| Status | Terminated |
| Reason | Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device Correction (UDMC) was sent to all affected Siemens Healthcare Diagnostic customers in the United States on June 28, 2013 via FedEx. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on June 27, 2013. FedEx Return Receipts will be used to confirm that the customers received the UMDC. If confirmation of receipt by any customer cannot be verified through a return receipt, a Siemens Technical Solutions Center Representative will contact those customers by telephone to ensure that they received the Urgent Medical |
| Quantity | 265 Cal A 6 packs (US and OUS) |
| Distribution | Worldwide Distribution-Nationwide including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NV, NY, OH, PA, TN, TX, VA, VT, and WV and the countries of Slovakia, Germany, Turkey, TW, HK, CH, TH, BR, CN, SG, and ZA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961510 | ACS FRT4 IMMUNOASSAY Ciba Corning Diagnostics Corp., Jun 17, 1996 |