VITROS Chemistry Products VALP Reagent Pack (2018-12-11)
- Starting date:
- December 11, 2018
- Posting date:
- January 9, 2019
- 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-68658
Affected products
VITROS Chemistry Products VALP Reagent Pack
Reason
Ortho Clinical Diagnostics (ORTHO) has initiated this recall as preliminary investigation determined that undetected variability in the release process caused a negative bias. Ortho has implemented interim corrective actions to help prevent future occurrences. Further actions will be implemented as appropriate. Alternate in-date VALP reagent has demonstrated acceptable accuracy during the investigation.
Affected products
VITROS Chemistry Products VALP Reagent Pack
Lot or serial number
25-5263
25-5503
25-5727
25-5974
25-6067
25-6393
Model or catalog number
680 1710
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES