Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Calibrator Kit 17
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 17 because calibrator values were assigned using a reference method that was not fully validated.
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 source text does not report any illnesses, injuries, or deaths, and the hazard is related to the accuracy of the calibration process rather than a direct physical or biological threat to the user, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/Catalog Number 6801701. This product is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS, VITROS 4600, and VITROS 5600 systems for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.
The recall was initiated because calibrator values for the affected lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to the assignment of calibrator values for the VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation 28.
The affected lots are 1732 (exp. 31-Jul-2014), 1743 (exp. 31-Jul-2014), 1753 (exp. 28-Feb-2015), and 1764 (exp. 31-Jul-2015). The recall covers 612 domestic units and 461 foreign units. Distribution was worldwide, including the United States (nationwide, including Puerto Rico) and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. Users should contact Ortho-Clinical Diagnostics for instructions on how to return the product.
The recalled product
- Product
- VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry…
- Manufacturer
- Ortho-Clinical Diagnostics
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)
- Lots 1732 (exp. 31-Jul-2014)
- 1743 (exp. 31-Jul-2014)
- 1753 (exp. 28-Feb-2015)
- 1764 (31-Jul-2015)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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