Recall Z-1556-2023— Ortho-Clinical Diagnostics, Inc.

Name: FDA recall Z-1556-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-10

Class II · Ongoing

Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2023-03-10. It names one FDA 510(k) clearance: K081543. 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 Immunodiagnostic Products Reagents Product Code: 6802413. Reason: 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.

Recalling firm: Ortho-Clinical Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-03-10
Firm location: Raritan, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K081543 — VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEMOrtho-Clinical Diagnostics, Inc.·cleared 2008-10-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.