Health product recall

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

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

VITROS ECI Immunodiagnostic Products Vitamin B12 Reagent Pack Controls & CA

Lot or serial number

2601

Model or catalog number

145 3489

Companies
Manufacturer
Ortho Clinical Diagnostics
Felindre Meadows
Pencoed, Bridgend
CF35 5PZ
UNITED KINGDOM