Ortho-Clinical Diagnostics, Inc. 2024-01-31 Health serious FDA
Health · FDA · Recall #FDA-Z-0772-2024
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 … Recall
Issued January 31, 2024 · Ortho-Clinical Diagnostics, Inc.
In January 2024, Ortho-Clinical Diagnostics, Inc. recalled the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
What you should do
- 1 Stop using VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Ortho-Clinical Diagnostics, Inc. to arrange your voluntary. See the official notice below for contact details.
- 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
- January 31, 2024
- Units affected
- Not reported
- Sold at
- Domestic distribution nationwide. OUS distribution to Bermuda, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Mexico, Sing
- Recall number
- FDA-Z-0772-2024
- 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 737th Health recall we've logged in 2024.