Acs FRT4 Immunoassay

• 3 recalls, same reason

  • Terminated Z-1254-2017 FDA Class II ·initiated 10 Jan 2017
  • Terminated Z-1256-2017 FDA Class II ·initiated 10 Jan 2017
  • Terminated Z-1255-2017 FDA Class II ·initiated 10 Jan 2017

  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.

• • Terminated Z-1970-2013 FDA Class III ·initiated 28 Jun 2013 ·on shared 510(k) K961510

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K961510 ↗

FDA Product Code

JJX

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K870965 Active Cleared 14 May 1987

See all devices from Ciba Corning Diagnostics Corp. →