Ortho-Clinical VITROS 350 Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 350 Chemistry Systems due to increased error codes when using specific calibrators.
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, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity recall involving a potential risk of harm without reported adverse events.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054. The recall affects units with Software Version 9.4 and below and Serial Numbers J27000001 through 27004539. The product is an in vitro diagnostic device used to perform clinical tests on serum, urine, and cerebral spinal fluid specimens.
The recall is due to increased U90-382 or 6LU condition codes generated by the system when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customer actions following these condition codes was noted. The recall is classified as Class II by the FDA.
The affected units were distributed worldwide, including the United States (885 units) and foreign markets (3,221 units). Distribution included Puerto Rico and countries such as Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. Users should contact Ortho-Clinical Diagnostics for further instructions regarding the software update or replacement.
The recalled product
- Product
- VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens.…
- Manufacturer
- Ortho-Clinical Diagnostics
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)
- Software Version 9.4 and below
- Serial Numbers J27000001 - 27004539
Distribution
Part of a larger recall action
This product is one of 5 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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