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

• • Terminated Z-1337-2013 FDA Class III ·initiated 3 Apr 2013 ·on shared 510(k) K973030

  Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results.

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

510(k) Number

K973030 ↗

FDA Product Code

JJY

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• 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

• Amerlite Ferritin II Assay

  Class II

  FDA 510(k) K952286 Active Cleared 20 Jun 1995

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