Z-1556-2023 Class II Ongoing
FDA device recall Z-1556-2023 was initiated by Ortho-Clinical Diagnostics, Inc. on March 10, 2023 and is designated Class II. Reason for recall: MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable The recall status is ongoing. Affected quantity: 4895 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 10, 2023
- Initiation Date
- March 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4895 units
Product Description
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 Immunodiagnostic Products Reagents Product Code: 6802413
Reason for Recall
MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable
Distribution Pattern
Nationwide including Puerto Rico and Bermuda Foreign: Australia Belgium Brazil Canada Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom
Code Information
UDI: 10758750002740 Serial Number Range: J56000143- J56004477