Ortho-Clinical Diagnostics Recalls VITROS LAC Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS LAC Slides because slide dispense cartridges may cause dispensing 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a mechanical dispensing issue rather than a direct health risk like contamination or mislabeling, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products LAC Slides, which are used to quantitatively measure lactate concentration in plasma. The recall involves slides packaged as 300 slides per pack (catalog number 8433880) and 90 slides per pack (catalog number 8150112). These products are used with VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
The recall is being conducted because Slide Dispense cartridges used with some of these VITROS Chemistry Product Slides are experiencing slide dispense issues. The affected units include 28,633 total units, with 14,634 units distributed domestically in the United States and 13,999 units distributed internationally. The distribution covers the United States (nationwide, including Puerto Rico) and various international locations including Australia, Brazil, Canada, and others.
Multiple lots are affected, with expiry dates through March 22, 2015. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry…
- 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 VITROS Chemistry LAC Slides Recalled Due to NAC Interference
FDA (Devices) · 2016-10-26
- ModerateOrtho-Clinical VITROS Lithium Slides Recalled for Imprecision
FDA (Devices) · 2017-03-22
- LowOrtho-Clinical Diagnostics Recalls VITROS Chemistry Products Cl- Slides
FDA (Devices) · 2018-09-19
- LowOrtho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Manufacturing Error
FDA (Devices) · 2013-07-03
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry Cl- Slides Due to Dispense Issues
FDA (Devices) · 2019-11-13
- SevereOrtho-Clinical Diagnostics Recalls VITROS TRIG Slides Due to Biased Results
FDA (Devices) · 2014-12-31