Abbott Point Of Care Inc. 2025-09-24 Health serious FDA
Health · FDA · Recall #FDA-Z-2582-2025
i-STAT CG4+ cartridge (white). List Number: 03P85-25. Recall
Issued September 24, 2025 · Abbott Point Of Care Inc.
In September 2025, Abbott Point Of Care Inc. recalled the i-STAT CG4+ cartridge (white). List Number: 03P85-25., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
What you should do
- 1 Stop using i-STAT CG4+ cartridge (white). List Number: 03P85-25. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Abbott Point Of Care 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
- Abbott Point Of Care Inc.
- Category
- Health
- Recall date
- September 24, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-2582-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Abbott Point Of Care Inc. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.