Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slide Dispense Cartridges
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slide Dispense cartridges due to slide dispense issues.
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 a mechanical 'slide dispense issue' rather than a direct biological or chemical contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides. The recall is being conducted due to slide dispense issues.
The affected products include VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack (catalog number 1202670) and 90 slides/pack (catalog number 8112724). These slides are used to quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
A total of 70,125 units were distributed, including 20,219 units domestically and 49,906 units internationally. The distribution was worldwide, including the United States (nationwide) and Puerto Rico, as well as international locations such as Australia, Brazil, Canada, and others. Multiple lots are affected, with expiry dates through 22-Mar-2015.
The recalled product
- Product
- VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 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 (2)
- Multiple lots affected
- with expiry dates through 22-Mar-2015
Distribution
Part of a larger recall action
This product is one of 37 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.
See all 37 products in this recall →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
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateOrtho-Clinical Diagnostics Recalls VITROS AMYL Slides Reagent for Imprecision
FDA (Devices) · 2020-06-24
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry Product Performance Verifier II
FDA (Devices) · 2020-06-24
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry Product Performance Verifier I
FDA (Devices) · 2020-06-24
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry Cl- Slides for Dispense Issues
FDA (Devices) · 2019-11-13
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry Cl- Slides Due to Dispense Issues
FDA (Devices) · 2019-11-13
- LowOrtho-Clinical VITROS Chloride Slides Recalled for Analytical Performance Issues
FDA (Devices) · 2018-09-26