Ortho-Clinical VITROS Software Recall Due to Calibration Failure
Ortho-Clinical Diagnostics is recalling VITROS Software Version 3.1 because calibration may not occur when using specific calibrator barcode labels.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Software Version 3.1, which is utilized on 4600 Chemistry Systems and 5600 Integrated Systems. The recall was initiated because calibration may not occur when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kit 2.
The affected units were distributed worldwide, including in the United States (Colorado, North Carolina, New Jersey, New York, Pennsylvania, Michigan, and West Virginia) and internationally to Canada, Japan, and Spain. The recall involves 12 units with System Product Codes 6802445 and 6802413.
This is a Class III recall, which indicates that the use of or exposure to the product is not likely to cause adverse health consequences. Users should contact Ortho-Clinical Diagnostics for further instructions regarding the software update or replacement.
The recalled product
- Product
- VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-qua
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- System Product Code: 1) 6802445
- 2) 6802413
Distribution
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