Ciba Corning Acs Progesterone Immunoassay

• 4 recalls, same reason

  • Terminated Z-1421-2017 FDA Class II ·initiated 4 Jan 2017
  • Terminated Z-1420-2017 FDA Class II ·initiated 4 Jan 2017
  • Terminated Z-1419-2017 FDA Class II ·initiated 4 Jan 2017
  • Terminated Z-1418-2017 FDA Class II ·initiated 4 Jan 2017

  DHEA-S causes falsely elevated progesterone results.

• 3 recalls, same reason

  • Terminated Z-1079-2016 FDA Class II ·initiated 4 Feb 2016 ·on shared 510(k) K932955
  • Terminated Z-1078-2016 FDA Class II ·initiated 4 Feb 2016 ·on shared 510(k) K932955
  • Terminated Z-1077-2016 FDA Class II ·initiated 4 Feb 2016 ·on shared 510(k) K932955

  ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay

• 3 recalls, same reason

  • Terminated Z-1231-2015 FDA Class II ·initiated 27 Jan 2015
  • Terminated Z-1230-2015 FDA Class II ·initiated 27 Jan 2015
  • Terminated Z-1229-2015 FDA Class II ·initiated 27 Jan 2015

  ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)

• • Terminated Z-0164-2015 FDA Class II ·initiated 26 Sep 2014 ·on shared 510(k) K932955

  Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.

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

510(k) Number

K932955 ↗

FDA Product Code

JLS

Device Class

Class I

Regulation

21 CFR Part 862.1620

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ciba Corning Magic(R) Lite Tu Immunoassay

  Class II

  FDA 510(k) K864132 Active Cleared 16 Dec 1986

• Gilford Uniqual Abnormal Control Serum/Unassayed

  Class I

  FDA 510(k) K860998 Active Cleared 3 Apr 1986

• Acs FRT4 Immunoassay

  Class I

  FDA 510(k) K961510 Active Cleared 17 Jun 1996

• Ciba Corning Certain Lyte

  Class I

  FDA 510(k) K894576 Active Cleared 30 Oct 1989

• Ciba Corning ACS;180 Dpd Assay

  Class I

  FDA 510(k) K963251 Active Cleared 15 Oct 1996

• Ciba Corning Magic Lite Chlamydia Immunoassay

  Class I

  FDA 510(k) K895122 Active Cleared 30 Oct 1989

See all devices from Ciba Corning Diagnostics Corp. →