CLASS II Device recall · Reported 8 Jan 2020 · FDA Enforcement Report

i-STAT cTnI cartridge recalled by Abbott Point Of Care

Abbott Point Of Care is recalling i-STAT cTnI cartridge, distributed in 29 states. The recall was initiated on 16 Oct 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesList Number: 06P23-25 UDI: (01)00054749001986

Quantity recalled3,465,875

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0761-2020
FDA event ID: 84166
Recalling firm: Abbott Point Of Care, Princeton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 16 Oct 2019
FDA classified: 31 Dec 2019
Reported: 8 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Oct 2019	Recall initiated by company
31 Dec 2019	Classified by FDA	+76 days
8 Jan 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

i-STAT cTnI cartridge

Where it was distributed

US: AK AL AZ CA CT DC FL GA HI IL IN KS KY MD MI MS NC NE NH NM NV NY OH OK OR PA SC SD TN TX VA WA WV WY

Alaska Alabama Arizona California Connecticut District of Columbia Florida Georgia Illinois Kansas Kentucky Maryland Michigan Mississippi North Carolina Nebraska New Hampshire New Mexico Nevada New York

Questions about this recall

Why was it 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.

Which lots are affected?

List Number: 06P23-25 UDI: (01)00054749001986

Where was it sold?

US: AK AL AZ CA CT DC FL GA HI IL IN KS KY MD MI MS NC NE NH NM NV NY OH OK OR PA SC SD TN TX VA WA WV WY

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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6 May 2026Device	CLASS II	i-STAT EG6+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
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24 Sep 2025Device	CLASS II	i-STAT EG7+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
24 Sep 2025Device	CLASS II	i-STAT CG8+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide

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