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Vitros Immunodiagnostic Products CA125 II Calibrator (2013-10-10)
- Starting date:
- October 10, 2013
- Posting date:
- November 25, 2013
- 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-36855
Recalled products
A. Vitros Immunodiagnostic Products CA125 II Calibrator
Reason
Ortho Clinical Diagnostics (OCD) has received customer complaints regarding a positive shift in patient results when using Vitros Immunodiagnostic products CA125 II reagent packs, lots 1260 and above, when compared to lot 1240. Customers are being informed regarding a shift in results that may be observed when performing patient sample correlation tests between Vitros CA125 II Calibrators and Reagent packs, lots 1220, 1230, 1240 and/or 1250 compared to lots 1260 and above.
Internal testing has determined that the signal for all levels of affected lots of Vitros CA125II Calibrator increased over the shelf life of the product, resulting in negatively biased patient and quality control results. Testing has confirmed that this issue is isolated only to lots 1220, 1230, 1240, and 1250.
Affected products
A. Vitros Immunodiagnostic Products CA125 II Calibrator
Lot or serial number
- 1220
- 1230
- 1240
- 1250
Model or catalog number
- 6800034
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics
Johnson & Johnson
500-100 Holmers Farm Way
High Wycombe, Buckinghamshire
HP12 4DP
UNITED KINGDOM