VITROS Chemistry Products VALP Reagent Pack (2018-12-11)

Starting date:

December 11, 2018

Posting date:

January 9, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68658

• Reason
• Affected products

Affected products

VITROS Chemistry Products VALP Reagent Pack

Reason

Ortho Clinical Diagnostics (ORTHO) has initiated this recall as preliminary investigation determined that undetected variability in the release process caused a negative bias. Ortho has implemented interim corrective actions to help prevent future occurrences. Further actions will be implemented as appropriate. Alternate in-date VALP reagent has demonstrated acceptable accuracy during the investigation.

Affected products