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