VITROS Chemistry Products 5,1 FS Chemistry System - dLDL Assay (2018-10-08)

Starting date:

October 8, 2018

Posting date:

November 2, 2018

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-68184

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  Reason
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  Affected products

Affected products

VITROS Chemistry Products 5,1 FS Chemistry System - dLDL Assay

Reason

Ortho Clinical Diagnostics (Ortho) has initiated this recall following complaints received for GENs 26 and 27 as well as internal testing of a new lot that determined that GENs 26 and 27 are negatively biased by approximately 15 to 20 mg/dL (0.38 to 0.51 mmol/L) across the measuring range.

Affected products