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Recall Observatory FDA recall evidence

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

June 28, 2013

Class III

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
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

    reason.no_named_rule · v1.0.0

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