Vitros Specialty Diluent

• 2 recalls, same reason

  • Terminated Z-1519-2014 FDA Class II ·initiated 26 Mar 2014
  • Terminated Z-1520-2014 FDA Class II ·initiated 26 Mar 2014

  Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor.

510(k) Number

K962235 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

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

See all devices from Johnson & Johnson Clinical Diagnostics, Inc. →