Device product
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.
Z-1970-2013
Product summary
- Event
- Event 65626
- Status
- Terminated
- Classification
- Class III
- Quantity
- 265 Cal A 6 packs (US and OUS)
- Official record key
device-enforcement:Z-1970-2013
Official wording
Reason: Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.
Code information: REF 10285904 (6 pack): 89983A77 16 Jul 2013, 90669A77 16 Jul 2013; REF 10285905 (6 pack - REF); 90705A77 16 Jul 2013
Distribution pattern: 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.
Derived failure modes
-
Unknown
Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.