Ortho-Clinical Diagnostics Recalls VITROS 250AT Chemistry System
Ortho-Clinical Diagnostics is recalling 57 VITROS 250AT Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.
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 hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 57 units of the VITROS 250AT Chemistry System, Product Code 1758143. The recall covers all lots of the device, which is used to perform discrete clinical tests on serum, urine, and cerebral spinal fluid specimens.
The recall was initiated because of potential negative drift in Creatine Kinase (CK) results when the system is used. The VITROS 250AT Chemistry System is distributed nationwide in the United States.
Healthcare facilities and laboratories should stop using the affected units and contact Ortho-Clinical Diagnostics for further instructions on the recall.
The recalled product
- Product
- VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR)…
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 57
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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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 4 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 · inaccurate results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
Similar recalls
- ModerateOrtho-Clinical VITROS 350 Chemistry System Software Recall
FDA (Devices) · 2016-03-16
- ModerateOrtho Clinical Diagnostics Recalls VITROS 250AT Chemistry Systems Due to Software Anomaly
FDA (Devices) · 2019-08-14
- ModerateOrtho-Clinical Diagnostics Recalls VITROS 4600 Chemistry System Software
FDA (Devices) · 2018-12-26
- ModerateOrtho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry System Software
FDA (Devices) · 2018-12-26
- HighOrtho-Clinical Diagnostics Recalls VITROS Chemistry CK Slides for Dispense Issues
FDA (Devices) · 2013-11-27
- HighOrtho-Clinical Diagnostics Recalls VITROS 3600 Immunodiagnostic System Software
FDA (Devices) · 2018-12-26