Ortho-Clinical VITROS Chemistry Calibration Data Module Recalled for Calibration Failure
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CDM PROM No. 0168 because it lacks calibration parameters for DT CRSC slides, preventing system calibration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II. The hazard is a functional defect (inability to calibrate) rather than a direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077. This product is used in conjunction with VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and the VITROS DT Calibrator Kit, Product Code 1957924, on the VITROS DT60/DT60 II Chemistry System.
The recall was initiated because customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides on the VITROS DT II System when using this specific Calibration Data Module. The source text states that CDM 168 does not contain the necessary calibration parameters for DT CRSC.
The recall involves 284 units in the US and 4,772 units outside the US. Distribution included the US states of AR, FL, IA, IL, KY, MI, MN, ND, NY, and VA, as well as Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. Users should stop using the affected Calibration Data Module and contact Ortho-Clinical Diagnostics for instructions.
The recalled product
- Product
- VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS…
- 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 (4)
- Calibration Data Module Rev. 0168
- REF 199 9077 used in conjuction with of VITROS Chemistry Products CRSC DT Slides
- Generation (GEN) 82
- Product Code 6802721.
Distribution
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