Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement Recalled by Abbott Point Of Care Inc. Due to Ionized calcium test on some i-STAT CG8+ and...

Date: December 22, 2020
Company: Abbott Point Of Care Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Point Of Care Inc. directly.

Affected Products

Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25

Quantity: 2,820,000 cartridges US and 2,273,453 catridges OUS

Why Was This Recalled?

Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Point Of Care Inc.

Abbott Point Of Care Inc. has 28 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report