Ortho-Clinical VITROS 250 Chemistry System Recalled for CK Result Drift
Ortho-Clinical Diagnostics is recalling 2,411 refurbished VITROS 250 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 risk of inaccurate diagnostic results (negative drift in CK), which is a risk-of-harm product where specific injury or illness has not been reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 2,411 units of the VITROS 250 Chemistry System Refurbished (Product Code 6801759, UDI # 10758750001330). The recall covers all lots of the product, which was distributed nationwide in the United States.
The recall was initiated because of potential negative drift in Creatine Kinase (CK) results when the system is used on the VITROS 250 and 350 Systems. The device performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens using methodologies including colorimetric, potentiometric, rate, and immuno-rate tests.
Healthcare facilities and laboratories that possess these units should stop using them for Creatine Kinase testing and contact Ortho-Clinical Diagnostics for further instructions on the recall process.
The recalled product
- Product
- VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and…
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 2,411
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.
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