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VITROS Immunodiagnostic Products HBsAg Controls (2016-06-23)
- Starting date:
- June 23, 2016
- Posting date:
- July 7, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-59250
Affected products
A. VITROS Immunodiagnostic Products HBsAg Controls
Reason
Ortho Clinical Diagnostics (Ortho) has initiated this recall due to the potential for higher than expected signal/cutoff (s/c) results outside the control's expected range when using Vitros HBsAg controls (the negative control). The positive shift in results occurs prior to the 5 day opened-reconstituted stability product claim for Vitros HBsAg controls, lots 0860, 0870, 0880, 0890 and 0908. A positive shift with the positive control may also be observed, but the shift is within the control's expected range.
Affected products
A. VITROS Immunodiagnostic Products HBsAg Controls
Lot or serial number
0860
0870
0880
0890
0908
Model or catalog number
6800598
Companies
- Manufacturer
-
ORTHO-CLINICAL DIAGNOSTICS
FELINDRE MEADOWS, PENCOED, BRIDGEND