Abbott Point Of Care Inc.: Medical Device Recall in 2025 - (Recall #: Z-2582-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

i-STAT CG4+ cartridge (white). List Number: 03P85-25.

Product Classification:

Class II

Date Initiated: August 21, 2025

Date Posted: September 24, 2025

Recall Number: Z-2582-2025

Event ID: 97442

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 9,067,050 units

Code Information:

List Number: 03P85-25. All lot numbers.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated