Vitros Immunodiagnostics Products Fsh Reagent Pack (Gem. 1005) Fsh Calibrators (GEM.C005)

• • Ongoing Z-1112-2022 FDA Class II ·initiated 25 Mar 2022

  Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.

• • Ongoing Z-0059-2019 FDA Class II ·initiated 12 Jul 2018

  The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

510(k) Number

K964720 ↗

FDA Product Code

CGJ

Device Class

Class I

Regulation

21 CFR Part 862.1300

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K973030 Active Cleared 4 Sep 1997

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  Class I

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  Class I

  FDA 510(k) K955904 Active Cleared 24 May 1996

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  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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