VITROS 5, 1 FS Chemistry System, VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System, and VITROS 4600 Chemistry System (2018-10-21)
- Starting date:
- October 21, 2018
- Posting date:
- November 15, 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-68222
Affected products
- VITROS 5,1 FS Chemistry System
- VITROS 5,1 FS Chemistry System (Refurbished)
- VITROS 3600 Immunodiagnostic System
- VITROS 5600 Integrated System
- VITROS 4600 Chemistry System
Reason
Under specific scenarios, a software anomaly will occur causing the VITROS Systems to incorrectly determine the reagent's on-analyzer stability time. When the anomaly occurs, the system could use reagents past their on-analyzer stability time without alerting the user with a condition code or flagging the associated results with an RE (Reagent Expired) code. In the event reagents are used beyond their specific on-analyzer stability times, the associated test results may be affected.
Affected products
-
VITROS 5,1 FS Chemistry System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
680 1375
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
B. VITROS 5,1 FS Chemistry System (Refurbished)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
6801890
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
C. VITROS 3600 Immunodiagnostic System
Lot or serial number
J36000773
J36000942
J36001003
J36001126
Model or catalog number
680 2783
680 2914
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
D. VITROS 5600 Integrated System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
680 2413
680 2915
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
E. VITROS 4600 Chemistry System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
680 2445
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES