VITROS ECI Immunodiagnostic Products Vitamin B12 Reagent Pack Controls & CA (2018-08-31)

Starting date:

August 31, 2018

Posting date:

September 17, 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-67760

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  Reason
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  Affected products

Affected products

VITROS ECI Immunodiagnostic Products Vitamin B12 Reagent Pack Controls & CA

Reason

Ortho Clinical Diagnostics confirmed that VITROS Vitamin B12 Reagent Pack 1/2, Lot 2601 exhibits the potential for an increased frequency of calibration failures. When a calibration failure occurs, customers have reported that their VITROS System generated the following condition codes to indicate that the calibrator signal index exceeds the limit:

• For VITROS 3600/5600 Systems: PW7-012 (Calibrator signal index above limit Level %d)
• For VITROS ECi/ECiQ Systems: 542-037 (542-037: Calibration %s Lot %s failed)

Our preliminary testing indicates that the calibration failure is related to the storage of a component used during the manufacture of some VITROS Vitamin B12 Reagent Packs 1/2, Lot 2601 and is not associated with VITROS Vitamin B12 Calibrators. Note: Not all reagent packs from Lot 2601 are affected.

Affected products