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 Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL Recalled by Mckesson Medical-Surgical Inc. Corporate Office Due to Facility Critical Temperature Excursions on 08-JAN 2024 in...

Date: January 9, 2024
Company: Mckesson Medical-Surgical Inc. Corporate Office
Status: Ongoing
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 Mckesson Medical-Surgical Inc. Corporate Office directly.

Affected Products

Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL

Quantity: 1 unit

Why Was This Recalled?

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mckesson Medical-Surgical Inc. Corporate Office

Mckesson Medical-Surgical Inc. Corporate Office has 276 total recalls tracked by RecallDetector.

Related Recalls

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