VITROS Chemistry Products 7% BSA & Urine Electrolyte Diluent (UED) (2019-10-21)
- Starting date:
- October 21, 2019
- Posting date:
- November 15, 2019
- 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-71603
Last updated: 2019-11-15
Affected Products
- VITROS Chemistry Products 7% BSA
- VITROS Chemistry Products Urine Electrolyte Diluent (UED)
Reason
Ortho Cinical Diagnostics determined that VITROS 7% BSA and VITROS Urine Electrolyte Diluent (UED) do not meet the current OAS time of 7 Days when stored on the Vitros 250/350 system in a 2ml cup only.
Affected products
-
VITROS Chemistry Products 7% BSA
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
8262487
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
B. VITROS Chemistry Products Urine Electrolyte Diluent (UED)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
111 0352
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES