Class II — Potential Health Hazard

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

i-STAT cTnI cartridge Recalled by Abbott Point Of Care Inc. Due to i-STAT¿ cTnI blue cartridges may generate a higher...

Date: October 16, 2019
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

i-STAT cTnI cartridge

Quantity: 3,465,875

Why Was This Recalled?

i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.

Where Was This Sold?

This product was distributed to 34 states: AL, AK, AZ, CA, CT, FL, GA, HI, IL, IN, KS, KY, MD, MI, MS, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WV, WY, DC

Affected (34 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