Ciba Corning Acs Prolactin Immunoassay

• 2 recalls, same reason

  • Terminated Z-2410-2012 FDA Class III ·initiated 7 Aug 2012 ·on shared 510(k) K904714
  • Terminated Z-2409-2012 FDA Class III ·initiated 7 Aug 2012

  ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40

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

510(k) Number

K904714 ↗

FDA Product Code

CFT

Device Class

Class I

Regulation

21 CFR Part 862.1625

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Ciba Corning Diagnostics Corp. →