The Recall Desk
ModerateFDA (Devices)·Z-1555-2023·Announced 2023-05-10

VITROS XT 7600 Analyzer Pack Opener May Not Remove Reagent Pack Caps

The MicroTip Pack Opener Assembly in VITROS XT 7600 laboratory analyzers may fail to properly remove or replace reagent pack caps, potentially causing unusable packs and delayed test results. Approximately 2,001 affected units were 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: This FDA Class II recall has no reported hospitalizations, illnesses, or injuries. The hazard is a functional failure in device operation that may delay clinical test results, not a direct patient safety risk.

Plain-English summary

The VITROS XT 7600 Integrated System is a laboratory analyzer used in clinical settings to measure various analytes from patient samples. The recall is related to the MicroTip Pack Opener Assembly component, which is used with microTip reagent packs.

The MicroTip Pack Opener Assembly may fail to properly remove or replace the caps on microTip reagent packs. When this malfunction occurs, reagent packs may become unusable, which can lead to delayed test results and operational disruptions in clinical laboratories.

This recall affects approximately 2,001 units of the VITROS XT 7600 system distributed nationwide, including Puerto Rico and Bermuda, as well as internationally in 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 affected serial numbers range from J76000109 to J76001492.

Laboratories using these systems should contact Ortho-Clinical Diagnostics, Inc. for instructions on remediation. To date, no injuries or illnesses have been reported associated with this issue.

The recalled product

Product
VITROS XT 7600 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 Immunodiagn
Manufacturer
Ortho-Clinical Diagnostics, Inc.
Category
Medical Device — Laboratory Analyzer
Hazard
  • pack-opener-malfunction
  • delayed-test-results

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: 10758750031610 Serial Number Range: J76000109- J76001492

Distribution

Distributed nationwide across the United States.

Related recalls

Same category