Ortho-Clinical Diagnostics Recalls VITROS 250 Chemistry System for CK Drift
Ortho-Clinical Diagnostics is recalling 5,020 VITROS 250 Chemistry Systems due to potential negative drift in Creatine Kinase 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 test results (negative drift in CK), which poses a risk of harm to patient care, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 5,020 units of the VITROS 250 Chemistry System (Product Code 8132086, UDI # 10758750004409). The recall covers all lots and was distributed nationwide in the United States. The device is used to perform discrete clinical tests on serum, urine, and cerebral spinal fluid specimens using methodologies such as colorimetric, potentiometric, rate, and immuno-rate tests.
The recall was initiated because of potential negative drift in Creatine Kinase (CK) results when the system is used. This issue may affect the accuracy of clinical test results for patients whose specimens are analyzed on these devices.
Healthcare facilities and laboratories should stop using the affected VITROS 250 Chemistry Systems and contact Ortho-Clinical Diagnostics for further instructions on the recall process.
The recalled product
- Product
- VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) 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
- 5,020
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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