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VITROS Integrated/ Chemistry Systems (2015-12-21)
- Starting date:
- December 21, 2015
- Posting date:
- January 25, 2016
- 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-56780
Afftected Products
- VITROS 250 Chemistry System
- VITROS 250 Chemistry System - Class 3
- VITROS 5,1 FS Chemistry System - Class II
- VITROS 5,1 FS Chemistry System - Instrument
- VITROS 350 Chemistry System - Vitros 350 Analyzer
- VITROS 350 Chemistry System - Analyzer
- VITROS 5600 Integrated System - Instrument
- VITROS 5600 Integrated System
- VITROS 4600 Chemistry System
Reason
Ortho-Clinical Diagnostics, inc. (ortho) initiated this urgent product correction notification due to the need to clarify operator actions following U90-382 or 6LU condition codes generated by the systems affected by this recall. U90-382 or 6LU condition codes are associated with wash errors that may occur when using VITROS chemistry products for Immuno-Rate assays (i.e. VITROS, CRBM, CRP, DGXN, and PHYT slides). If a U90-382 or 6LU condition code (i.e., associated with a wash error) occurs, the condition code text located on the VITROS system and other user documentation indicates to dilute the sample. However, dilution may not be the appropriate action for all scenarios.
Affected products
A. VITROS 250 Chemistry System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 6801759
- 813 2086
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
B. VITROS 250 Chemistry System - Class 3
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 6801759
- 813 2086
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
C. VITROS 5,1 FS Chemistry System - Class II
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
D. VITROS 5,1 FS Chemistry System - Instrument
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
E. VITROS 350 Chemistry System - Vitros 350 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
680 2153
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
F. VITROS 350 Chemistry System - Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
680 2153
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
G. VITROS 5600 Integrated System - Instrument
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
680 2413
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
H. VITROS 5600 Integrated System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
680 2413
Companies
- Manufacturer
-
Ortho Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
I. 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