Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Calibrator Kit 29
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 29 because incorrect calibration mathematics may cause biased test results for total iron-binding capacity.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is limited to inaccurate diagnostic data rather than direct physical injury or contamination.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 29 (REF/Product Code 680 2344) used with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30) and Assay Data Disk (ADD). The recall involves Lots 2915 (exp. December 2016) and 1995 (exp. July 2016). The product is used to calibrate VITROS 5,1 FS, 4600, and 5600 Chemistry Systems for the quantitative measurement of total iron-binding capacity (TIBC).
The recall was initiated after Ortho-Clinical Diagnostics received customer complaints regarding biased results. The company's investigation confirmed that incorrect calibration mathematics were assigned to the affected calibrator lots. This error may lead to inaccurate test results for total iron-binding capacity.
The affected units were distributed worldwide, including the United States (nationwide and Puerto Rico) and internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, and Venezuela. A total of 1,517 units were distributed in the US and 842 units were distributed internationally. Users should stop using the affected lots and contact Ortho-Clinical Diagnostics for instructions on replacement or return.
The recalled product
- Product
- VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release…
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
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 (1)
- Lots 2915 (exp. December 2016) and 1995 (exp. July 2016)
Distribution
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