VITROS High Sample Diluent A Reagent Produces Lower Than Expected Results
Ortho-Clinical Diagnostics is recalling VITROS High Sample Diluent A Reagent Pack Lot 2190 because it produces lower than expected TSH test results. The recall affects 1,416 units distributed worldwide.
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: FDA Class II medical device recall. The defect causes inaccurate diagnostic test results in TSH testing, posing a risk of patient harm through misdiagnosis or missed diagnoses. No illnesses or injuries have been reported.
Plain-English summary
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack, Lot 2190, manufactured by Ortho-Clinical Diagnostics, Inc., has been recalled by the FDA. The recall involves 1,416 units of this diagnostic reagent.
The defect is that when this diluent is used with VITROS Immunodiagnostic Products TSH Reagent Pack, it produces lower than expected results, potentially leading to inaccurate diagnostic test outcomes.
The affected reagent was distributed nationwide throughout the United States and internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, the United Kingdom, and several European countries including France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, Belgium, and the Netherlands.
This is an FDA Class II recall issued under recall number Z-0503-2022.
The recalled product
- Product
- VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 1,416
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 (2)
- Lot # 2190
- Product code(unique Device Identifier): 8430373 (10758750004898)
Distribution
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