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Serious recall: Injury is possible or has been reported. Take action promptly.

Ortho-Clinical Diagnostics, Inc. 2023-05-10 Health serious FDA
Health · FDA · Recall #FDA-Z-1556-2023

VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative,… Recall

Issued May 10, 2023 · Ortho-Clinical Diagnostics, Inc.

In May 2023, Ortho-Clinical Diagnostics, Inc. recalled the VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative,…, a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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

What you should do

  1. 1 Stop using VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative,… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Ortho-Clinical Diagnostics, Inc. to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Ortho-Clinical Diagnostics, Inc.
Category
Health
Recall date
May 10, 2023
Units affected
Not reported
Sold at
Nationwide including Puerto Rico and Bermuda Foreign: Australia Belgium Brazil Canada Chile China Colombia Denmark France Germany India It
Recall number
FDA-Z-1556-2023
Made in
United States
Issuing agency
FDA

In context

  • Ortho-Clinical Diagnostics, Inc. has 6 recalls in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 903rd Health recall we've logged in 2023.
Read the official FDA notice

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