VITROS ECi Immunodiagnostic Products (2018-11-01)
- Starting date:
- November 1, 2018
- Posting date:
- November 28, 2018
- 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-68370
Affected products
- VITROS ECi Immunodiagnostic Products NTproBNP Reagent Pack
- VITROS ECi Immunodiagnostic Products TSH Reagent Pack
- VITROS ECi Immunodiagnostic Products Prolactin Reagent Pack
- VITROS ECi Immunodiagnostic Products FSH Reagent Pack
- VITROS ECi Immunodiagnostic Products Folate Reagent Controls & Calibrators
- VITROS ECi Immunodiagnostic Products Free PSA Reagent Pack
Reason
Ortho Clinical Diagnostics determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions for Use (IFU).
Historically, these assays were evaluated for the interference consistent with CLSI document EP7. Biotin was tested and was not found to cause a bias of >/=10%.
To assess the potential interference of biotin supplements on VITROS MicroWell Assays, Ortho performed more robust testing using the new CLSI guidelines EP7 and EP37 and determined that the information in the current IFUs is no longer supported for these five (5) assays. The concentration of biotin that causes >/=10% bias is listed in the customer letter.
Affected products
A. VITROS ECi Immunodiagnostic Products NTproBNP Reagent Pack
Lot or serial number
ALL EXPIRED/IN-DATE/FUTURE LOT
Model or catalog number
680 2156
Companies
- Manufacturer
-
ORTHO-CLINICAL DIAGNOSTICS
Felindre Meadows, Pencoed, Bridgend
Great Britain
CF35 5PZ
UNITED KINGDOM
B. VITROS ECi Immunodiagnostic Products TSH Reagent Pack
Lot or serial number
ALL EXPIRED/IN-DATE/FUTURE LOT
Model or catalog number
191 2997
Companies
- Manufacturer
-
Ortho Clinical Diagnostics
Felindre Meadows
Pencoed, Bridgend
CF35 5PZ
UNITED KINGDOM
C. VITROS ECi Immunodiagnostic Products Prolactin Reagent Pack
Lot or serial number
ALL EXPIRED/IN-DATE/FUTURE LOT
Model or catalog number
184 9793
Companies
- Manufacturer
-
Ortho Clinical Diagnostics
Felindre Meadows
Pencoed, Bridgend
CF35 5PZ
UNITED KINGDOM
D. VITROS ECi Immunodiagnostic Products FSH Reagent Pack
Lot or serial number
ALL EXPIRED/IN-DATE/FUTURE LOT
Model or catalog number
193 1922
Companies
- Manufacturer
-
Ortho Clinical Diagnostics
Felindre Meadows
Pencoed, Bridgend
CF35 5PZ
UNITED KINGDOM
E. VITROS ECi Immunodiagnostic Products Folate Reagent Controls & Calibrators
Lot or serial number
ALL EXPIRED/IN-DATE/FUTURE LOT
Model or catalog number
151 3266
Companies
- Manufacturer
-
Ortho Clinical Diagnostics
Felindre Meadows
Pencoed, Bridgend
CF35 5PZ
UNITED KINGDOM
F. VITROS ECi Immunodiagnostic Products Free PSA Reagent Pack
Lot or serial number
ALL EXPIRED/IN-DATE/FUTURE LOT
Model or catalog number
684 2845
Companies
- Manufacturer
-
Ortho Clinical Diagnostics
Felindre Meadows
Pencoed, Bridgend
CF35 5PZ
UNITED KINGDOM