Diagnostic Calibrator Kit Recalled for Software Defect Affecting System Calibration
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 9 due to incorrect calibration software (DRVs 6194-6200) that prevents laboratory systems from successfully calibrating, causing delayed test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall for a functional defect (incorrect calibration software) that prevents proper system calibration. No illnesses, injuries, or deaths have been reported; the impact is delayed test results rather than direct patient harm. Per the rubric, Class II recalls without reported hospitalization or injury are scored as Moderate (2).
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 9 (Product Code: 8568040) used to calibrate VITROS diagnostic chemistry systems. The calibration disk software versions (Data Release Versions 6194 through 6200) contain incorrect calibration mathematics that prevent the VITROS 250/350 Chemistry System from successfully calibrating, resulting in delayed test results.
This recall affects VITROS PHYT Slides of generation 22 (GEN 22) across all lots. Approximately 17,396 units have been distributed worldwide, including throughout the United States. The affected systems include VITROS 250/350, 5.1 FS, 4600, XT 3400, 5600, and XT 7600 Chemistry Systems.
The recalled product
- Product
- VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- calibration-failure
- delayed-test-results
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 (6)
- UDI-DI: 10758750005031 Kit Lots/Exp. Date: 0911 24-MAY-2023
- 0921 04-OCT-2023
- 0942 06-JUN-2024
- 0980 26-OCT-2022
- 0991 01-MAR-2023 VITROS Chemistry Products PHYT Slides
- GEN 22
Distribution
Distributed nationwide across the United States.
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