VITROS Immunodiagnostic Products TT4 Reagent Pack (2020-03-16)

Starting date:

March 16, 2020

Posting date:

April 17, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72785

Last updated: 2020-04-17

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  Reason
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  Affected products

Affected Products

VITROS Immunodiagnostic Products TT4 Reagent Pack

Reason

Ortho Clinical Diagnostics (Ortho) has confirmed that Vitros TT4 Reagent Packs, lot 2340 exhibits an increase in the frequency of unsuccessful calibrations.

Affected products