Agency classClass IIOur severity:High FDA (Devices)·Z-1936-2019·Announced 2019-07-10

Ortho-Clinical VITROS 350 Chemistry System Recalled for CK Drift

Ortho-Clinical Diagnostics is recalling VITROS 350 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 3/5 (High).

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 involves a medical device with a potential for inaccurate test results (negative drift in CK), which poses a risk of harm to patients through misdiagnosis or treatment errors, but no injuries or illnesses have been reported.

Plain-English summary

Ortho-Clinical Diagnostics is recalling 3,889 units of the VITROS 350 Chemistry System (Product Code 6802153, UDI # 10758750002054). The recall covers all lots and involves units distributed nationwide in the United States. The system is used to perform discrete clinical tests on serum, urine, and cerebral spinal fluid specimens using multi-layered VITROS Slides.

The recall was initiated because of potential negative drift in Creatine Kinase (CK) results when the system is used. This issue may also affect the VITROS 250 System. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.

Healthcare facilities and users of the VITROS 350 Chemistry System should contact Ortho-Clinical Diagnostics for instructions on how to address the recall. The source text does not provide specific consumer action steps beyond the general recall notification.

The recalled product

Product: VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) 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
Category: Medical Device — Clinical Laboratory Equipment
Hazard: inaccurate-test-results
Affected units: 3,889

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 →

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · inaccurate test results