Ortho-Clinical Diagnostics Recalls VITROS 5600 Chemistry Systems
Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to increased error codes when using a specific calibrator kit.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes a software/calibration error leading to condition codes, with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems, Catalog Number 6802413, with Unique Device Identifier Number 10758750002740. The recall affects units with Software Version 3.2 and below and Serial Numbers J56000024 through 56002339. The product is an in vitro diagnostic (IVD) used for the quantitative, semi-quantitative, and qualitative measurement of various clinical analytes.
The recall was initiated because of an increased number of U90-382 or 6LU condition codes generated by the VITROS 5600 Chemistry System when used with Calibrator Kit 9, Lot 954. The company noted a trend of complaints regarding customer actions taken in response to these specific condition codes. This issue is related to a previous recall of the VITROS Calibrator Kit 9, Lot 954.
The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. A total of 1,009 units were distributed in the US and 1,003 units were distributed in foreign countries. Users should contact Ortho-Clinical Diagnostics for instructions on how to proceed with the recall.
The recalled product
- Product
- VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS…
- 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 3.2 and below
- Serial Numbers J56000024 - 56002339
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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