Vitros Immunodiagnostics Product - Total T3 Reagent Pack (Gem .101) and Total Caliibration (GEM.C010)

• • Terminated Z-1707-2015 FDA Class III ·initiated 6 May 2015

  The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.

• • Terminated Z-0765-06 FDA Unclassified (pre-2012) ·initiated 28 Mar 2006

  Firm received complaints of biased results when using VITROS Signal Reagent, Lots 8350 and 8530. VITROS Signal Reagent is used with the VITROS Immunodiagnostic ECi/ECiQ laboratory system, and when used may produce inaccurate test results in some cases.

• • Terminated Z-0558-03 FDA Unclassified (pre-2012) ·initiated 10 Jan 2003 ·on shared 510(k) K964310

  Label printing irregularities on cartons and/or bottles.

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

510(k) Number

K964310 ↗

FDA Product Code

CDP

Device Class

Class II

Regulation

21 CFR Part 862.1710

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Vitros Immunodiagnostics Products/Ck-Mb Reagent Pack(GEM.1300)/Ck-Mb Calibrators (GEM.C300)

  Class I

  FDA 510(k) K973030 Active Cleared 4 Sep 1997

• Vitros Immunodiagnostics Products Lh Reagent Pack (GEM.1055) and Lh Calibrators (GEM.CO55) Open recall

  Class I

  FDA 510(k) K964982 Active Cleared 20 Feb 1997

• Ektachem Dt Ldl Cholesterol Kit

  Class I

  FDA 510(k) K955904 Active Cleared 24 May 1996

• Vitros Immunodiagnostic Products Range Verifiers

  Class I

  FDA 510(k) K973517 Active Cleared 25 Sep 1997

• Vitros Immunodiagnostics Products Free T4 Reagent Pack (GEM.1015) Free T4 Calibrators (GEM.CO15)

  Class II

  FDA 510(k) K965142 Active Cleared 18 Mar 1997

• Ektachem Clinical Chemistry Calcium (Ca) Slide

  Class II

  FDA 510(k) K961226 Active Cleared 7 May 1996

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