Ortho-Clinical Diagnostics, Inc. 2023-08-02 Health moderate FDA
Health · FDA · Recall #FDA-Z-2225-2023
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use… Recall
Issued August 2, 2023 · Ortho-Clinical Diagnostics, Inc.
In August 2023, Ortho-Clinical Diagnostics, Inc. recalled the VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
What you should do
- 1 Stop using VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use… 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
- August 2, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the state of CA.
- Recall number
- FDA-Z-2225-2023
- 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.