Recall Z-2582-2025— Abbott Point Of Care Inc.
Class II · Ongoing
Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2025-08-21. It names 3 FDA 510(k) clearances: K244014, K982071, K940918. Product: i-STAT CG4+ cartridge (white). List Number: 03P85-25.. Reason: 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..
- Recalling firm
- Abbott Point Of Care Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-21
- Firm location
- Princeton, NJ, United States
510(k) clearances named in this recall
3 on FDA's record- K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System
- K982071 — I-STAT LACTATE TEST
- K940918 — I-STAT 200 PORTABLE CLINICAL ANALYZER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.