VITROS Chemistry Calibrator Kit Cannot Calibrate Vancomycin Reagent
Ortho-Clinical Diagnostics is recalling 132 units of VITROS Chemistry Calibrator Kit 11 with defective Assay Data Disk versions due to inability to calibrate vancomycin reagent, delaying laboratory testing.
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: FDA Class II medical device recall with no reported illnesses, injuries, or deaths. The hazard is a software defect causing functional failure of the calibrator kit, preventing reagent calibration and resulting in testing delays, but without documented patient harm.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 132 units of the VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions 6215 through 6223. The product is used to calibrate vancomycin measurement systems on VITROS 5600/XT 7600 and VITROS 5.1 FS/4600 Chemistry Systems in clinical laboratories and healthcare facilities.
The affected calibrator kits cannot properly calibrate the vancomycin reagent due to a defect in the Assay Data Disk software. This prevents the diagnostic systems from conducting vancomycin testing, resulting in delays to laboratory operations. The recalled lot number is 1172 with expiration date 20-OCT-2023.
Healthcare providers and diagnostic laboratories should immediately stop using the affected calibrator kits and contact Ortho-Clinical Diagnostics for replacement units. The product was distributed nationwide and internationally to Brazil, Chile, and Colombia.
The recalled product
- Product
- VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600…
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 132
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)
- UDI-DI: 10758750006601 Lot Number: 1172 Exp. 20-OCT-2023
Distribution
Distributed nationwide across the United States.
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