Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products FS Calibrator 1
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products FS Calibrator 1 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 validation process of the reference method rather than a direct physical defect or contamination.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS (R) Chemistry Products FS Calibrator 1, Product Code/Catalog Number 6801873. This product is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. The recall affects Lots 91131 (exp. 07-Mar-2015) and 91241 (exp. 28-Feb-2016).
The recall was initiated because calibrator values assigned for the calibrator kit 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 calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28.
The affected units were distributed 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. A total of 464 units were distributed domestically and 361 units were distributed foreign. Users should stop using the affected product and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600…
- 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 91131 (exp. 07-Mar-2015) and 91241 (exp. 28-Feb-2016)
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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