Ortho-Clinical Diagnostics Recalls VITROS CRBM Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS CRBM Slides because of slide dispense issues. The slides are used to measure carbamazepine levels in serum and plasma.
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 hazard involves a mechanical dispense issue rather than a direct biological or chemical contamination, and no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack (catalog number 8892382). The recall is due to slide dispense issues with the Slide Dispense cartridges used with these products.
These slides are used to quantitatively measure carbamazepine (CRBM) concentration in serum and plasma. They are compatible with VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
The recall affects 12,484 units, with 9,040 units distributed domestically in the United States and 3,444 units distributed internationally. Multiple lots are affected, with expiry dates through March 22, 2015. Distribution was worldwide, including the United States (nationwide), Puerto Rico, and various international locations.
The recalled product
- Product
- VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
- 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 →- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Carbamazepine Slides Due to Potential Bias
FDA (Devices) · 2014-04-23
- LowOrtho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Manufacturing Error
FDA (Devices) · 2013-07-03
- LowOrtho-Clinical Diagnostics Recalls VITROS Chemistry Products Cl- Slides
FDA (Devices) · 2018-09-19
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry Cl- Slides Due to Dispense Issues
FDA (Devices) · 2019-11-13
- ModerateOrtho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Result Bias
FDA (Devices) · 2016-12-28
- ModerateOrtho-Clinical VITROS Lithium Slides Recalled for Imprecision
FDA (Devices) · 2017-03-22