Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). F

Recalled August 21, 2013 · FDA recall Z-1970-2013 · Siemens Healthcare Diagnostics

Hazard

Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay. · FDA Class III

Units

265 Cal A 6 packs (US and OUS)

Sold at

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.

Description

Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.

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.

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →