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Terminated

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.

FDA Recall Z-1970-2013 · Posted 2013-08-14

Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeJIS
Date Initiated2013-06-28
Date Terminated2014-07-25
Product Quantity265 Cal A 6 packs (US and OUS)

Reason for Recall

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

Firm 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 Device Correction and completed the required actions. These notices inform the customer that they should discontinue the use of Calibrator A, lots ending in 77, for use with the ADVIA Centaur Systems T4 assay. Customers are informed that they may continue to use Calibrator A lot CA77 with the other assays FT3, FT4, Total T3, T-Uptake. For questions or additional information contact your local Technical Support Provider or Distributor.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961510ACS FRT4 IMMUNOASSAYCiba Corning Diagnostics Corp. · 1996-06-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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