The Recall Desk
ModerateFDA (Devices)·Z-1557-2023·Announced 2023-05-10

VITROS 5600 Integrated System MicroTip Pack Opener Assembly Defect

Refurbished VITROS 5600 diagnostic systems may have a defective MicroTip Pack Opener Assembly that fails to properly remove or replace pack caps, potentially causing delayed test results. Ortho-Clinical Diagnostics is recalling 1,148 units distributed nationwide and internationally.

What this means for you

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 device with no reported illnesses, injuries, or hospitalizations. The hazard is an operational defect (delayed test results) rather than a safety-critical failure, fitting the Moderate classification per the rubric.

Plain-English summary

Ortho-Clinical Diagnostics, Inc. is recalling 1,148 refurbished VITROS 5600 Integrated Systems (Product Code 6802915). The systems were distributed nationwide, including Puerto Rico and Bermuda, and internationally to 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 MicroTip Pack Opener Assembly in affected units may fail to properly remove or replace MicroTip Pack Caps. If a pack becomes unusable due to this defect, test results may be delayed.

Affected units can be identified by serial numbers ranging from J56000147 to J56003653 and UDI 10758750007110. Healthcare facilities using the VITROS 5600 system should verify whether their unit falls within the affected serial number range.

The recalled product

Product
VITROS 5600 Integrated System - Refurbished . 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.
Category
Medical Device — Clinical Laboratory Equipment
Hazard
  • equipment-malfunction

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: 10758750007110 Serial Number Range: J56000147- J56003653

Distribution

Distributed nationwide across the United States.

Related recalls

Same category