—#148887

Product

Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)

FDA product code: DDR — Myoglobin, Antigen, Antiserum, Control
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K122599
Affected lot / code info: Kit Lots ending in 63 and 64 as follows: 65710A63, 77825A63, 99481A64, 08835A64, 22955A64

Why it was recalled

Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction (UMDC) to customers in the US on August 8, 2016, to be delivered to customers on August 9, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on August 8, 2016. The communications notify customers of the failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization. The communications also inform customers that analytical sensitivity and alignment to the internal standardization will be restored with the release of Calibrator U kit lots ending in 65. Customers may continue to use Calibrator U lots CU63 and CU64 with any indate reagent kit lot, current QC ranges and current Master Curve Material lot 45719. Revised QC targets and ranges are located on the Bio-Rad website at QCnet.com for use with CU65 and higher. For further questions, please call (508) 668-5000.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: Worldwide Distribution - Nationwide Distribution including the countries of: Argentina Australia Brazil Canada Chile China Ecuador India Japan Korea Mexico Malaysia Peru Philippines Saudi Arabia Singapore Taiwan Vietnam South Africa

Timeline

Recall initiated: 2016-08-08
Terminated: 2018-10-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148887. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.