Ortho-Clinical Diagnostics, INc. 2023-09-27 Health serious FDA
Health · FDA · Recall #FDA-Z-2624-2023
VITROS XT Chemistry Products ALKP Slides Recall
Issued September 27, 2023 · Ortho-Clinical Diagnostics, INc.
In September 2023, Ortho-Clinical Diagnostics, INc. recalled the VITROS XT Chemistry Products ALKP Slides, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.
What you should do
- 1 Stop using VITROS XT Chemistry Products ALKP Slides 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
- September 27, 2023
- Units affected
- Not reported
- Sold at
- Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to countries of: Bermuda, Belgium, Australia, Brazil, Canada, Chile,
- Recall number
- FDA-Z-2624-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Ortho-Clinical Diagnostics, INc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.