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VITROS recallZ-1555-2023 · Ortho-Clinical Diagnostics, Inc. · initiated Mar 10, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

Ortho Clinical issued Important Product Correction letter on 3/10/23 to customers with VITROS XT7600 & 5600 Integrated Systems (CL2023-061) and instructed: Until further notice, Ortho recommends loosening and then retightening all caps for MicroTip reagents or diluents immediately prior to loading them onto the system. Per the V-Docs/Maintenance Troubleshooting Guide instructions, Manual MicroTip Reagent Pack Cap Removal, Chapter 6 Troubleshooting, Remove reagent pack caps manually if they become too tight for the MICROTIP PACK OPENER to uncap. The purpose of executing this procedure is to loosen the caps without removing them, and then manually tighten the caps. For VITROS 5600: J33044 Chapter 6 Troubleshooting: Manual MicroTip Reagent Pack Cap Removal. For VITROS XT7600 Chapter 6 Troubleshooting: Manual MicroTip Reagent Pack Cap Removal " Complete the enclosed Confirmation of Receipt form no later than March 24, 2023. " Please forward this notification if the affected product was distributed outside of your facility. " Save this notification with your user documentation or post this notification by each VITROS 5600 or XT 7600 System until root cause investigation is completed. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care" Technical Solutions Center. Contact Information Ortho Care Technical Solutions Center at 1-800-421-3311

Recall details

Recall number
Z-1555-2023
Status
Open, Classified
Initiated by the company
Mar 10, 2023
Posted by the FDA
May 4, 2023
Recalling firm
Ortho-Clinical Diagnostics, Inc.
Quantity
2001 units
Product code
JJE
FDA submissions
K182063
Distribution
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

Product description

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 Immunodiagnostic Products Reagents Product Code: 6844461

Code information (models, lots, serial numbers)

UDI: 10758750031610 Serial Number Range: J76000109- J76001492

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 92055).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page