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Terminated

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 Recall Z-1256-2017 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeJJX
Date Initiated2017-01-10
Date Terminated2019-07-16
Product Quantity194 kits

Reason for Recall

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.

Firm Action

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.

Root Cause

Unknown/Undetermined by firm

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

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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