VITROS Chemistry FS Diluent Pack 3 Recalled for Negatively Biased Test Results
Ortho-Clinical Diagnostics is recalling VITROS Chemistry FS Diluent Pack 3, Lot 01-1645, because it may produce negatively biased results when used with CRP slides, potentially affecting patient diagnosis and care.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a diagnostic accuracy defect with no reported illnesses or injuries. The negatively biased test results constitute a risk-of-harm to patients through potential diagnostic errors, meeting the High severity criterion for risk-of-harm products without reported incident.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 (Model/Catalog Number 6801754). The diluent is used in laboratory diagnostic testing and may produce negatively biased results when used to dilute patient samples for testing with VITROS Chemistry Products CRP (C-Reactive Protein) slides.
When test results are negatively biased, the reported values may be lower than the patient's actual values. This could lead to missed or delayed diagnoses if results are not independently verified or if clinical decisions are made based solely on the biased results.
This product was distributed worldwide, including in the United States (Florida, Illinois, New York, and Pennsylvania) and internationally to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Spain, Singapore, Sweden, The Netherlands, and the United Kingdom.
Healthcare facilities that received this product with the specified lot number should contact Ortho-Clinical Diagnostics for guidance regarding proper handling and verification of any test results obtained with this diluent.
The recalled product
- Product
- VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- Affected units
- 1,000
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)
- Lot Code: Model No 6801754
- UDI-DI 10758750007004
- Lot Number 01-1645
- Expiration Date: 05-Jul-2024
Distribution
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