Ortho-Clinical VITROS Sodium Slides Recalled for Potential Positively Biased Results
Ortho-Clinical Diagnostics is recalling VITROS Sodium Slides due to a potential for positively biased results. The recall covers multiple generations and expiry dates distributed globally.
What this means for you
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: The recall is classified as FDA Class II and involves a risk-of-harm product (medical diagnostic) where the hazard is potential bias in results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Sodium Slides, Catalog # 837 9034, due to a potential for positively biased results. The affected products include UDI 10758750004812 and Generations 8, 13, 14, 16, 17, and 18, with expiry dates ranging from November 1, 2018, to November 1, 2019.
The recall is classified as Class II by the U.S. Food and Drug Administration. The products were distributed in the United States and internationally, including Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, the UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and the Netherlands.
Healthcare facilities and users of these diagnostic slides should stop using the affected products and contact Ortho-Clinical Diagnostics for further instructions on handling or returning the items.
The recalled product
- Product
- VITROS Sodium Slides, Catalog # 837 9034
- 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 (5)
- UDI - 10758750004812 GENs- 8
- 13
- 14
- 16
- 17 & 18 Expiry Dates: 01-Nov-2018 through 01-Nov-2019
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Ortho-Clinical Diagnostics
See all →- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02