—#152665

Product

Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)

FDA product code: JJX — Single (Specified) Analyte Controls (Assayed And Unassayed)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K961510
Affected lot / code info: Lot Numbers: 07996A90 21172A90 27221A90 44366A90 63785A90 Exp. Date: 2017/07/24

Why it was recalled

Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay. The performance of the FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur CP System is not affected. Customers may continue to use Calibrator A kit lots ending in 90 for the ADVIA Centaur Systems FT3, T3, T4 and TUp assays.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

Siemens issued Urgent Medical Device Recall (UMDR) sent to Siemens Healthcare Diagnostics customers in the United States on January 10, 2017 to be delivered to customers on January 11, 2017. An Urgent Field Safety Notice (UFSN) was sent out for distribution to customers outside the United States on January 10, 2017. The customer distribution included all customers that have received ADVIA Centaur Systems Calibrator A kit lots ending in 90 and ADVIA Centaur FT4 ReadyPacks. These notices inform the customer a negative bias has been confirmed for the ADVIA Centaur FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay. ADVIA Centaur FT4 assay customers using the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems were directed to discontinue the use of Calibrator A kit lots ending in 90 and instead use Calibrator A kit lots ending in 91 and above to calibrate the FT4 assay.

Recalling firm

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

Distribution

Distribution pattern: Nationwide. Afghanistan, Albania, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vatican, Vietnam

Timeline

Recall initiated: 2017-01-10
Terminated: 2019-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152665. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.