VITROS 5600 system pack opener assembly may not function properly
The MicroTip Pack Opener Assembly on VITROS 5600 systems may fail to remove or replace pack caps properly, making packs unusable and delaying clinical test results. Approximately 4,895 units were distributed.
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: FDA Class II medical device recall with no reported illnesses, injuries, or deaths. The hazard is a device malfunction causing operational disruption (delayed test results) rather than a direct patient safety risk.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling the VITROS 5600 Integrated System due to a potential defect in the MicroTip Pack Opener Assembly. The assembly may fail to properly remove or replace the caps on MicroTip reagent packs.
When the defect occurs, MicroTip reagent packs may become unusable, resulting in delayed clinical test results. The VITROS 5600 is used in clinical laboratories for quantitative, semi-quantitative, and qualitative measurement of various analytes of clinical interest.
Approximately 4,895 units were distributed nationwide, including Puerto Rico and Bermuda. The recalled systems also reached international markets including Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and the United Kingdom.
The recalled product
- Product
- VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS…
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- Affected units
- 4,895
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)
- UDI: 10758750002740 Serial Number Range: J56000143- J56004477
Distribution
Part of a larger recall action
This product is one of 3 recalled by Ortho-Clinical Diagnostics, Inc. 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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