HIGHFDA DEVICE

i-STAT EG6+ cartridge; List Number: 03P77-25;

Abbott Point Of CareHealth & Personal CareMedical DevicesList Number: 03P77-25UDI-DI: 00054749000050Lot number: N25223A

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
April 1, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
April 1, 2026
Hazard Level
HIGH
Brand
Abbott Point Of Care
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Abbott Point Of Care
Model numbers
List Number: 03P77-25, UDI-DI: 00054749000050, Lot number: N25223A
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    April 1, 2026

  2. Reported by FDA DEVICE

    May 6, 2026

  3. RecallRadar source check

    May 13, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abbott Point Of Care Inc. or your healthcare provider for instructions. Notification method: Letter

Get instant alerts for Abbott Point Of Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Full Description

i-STAT EG6+ cartridge; List Number: 03P77-25;. Reason: Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.. Classification: Class II. Quantity: 30775 units (25625 US, 5150 OUS). Distribution: Worldwide distribution - US Nationwide and the countries of Canada, AUSTRIA, BANGLADESH, BELGIUM, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, LUXEMBOURG, MAURITIUS, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

Want to Know First?

Get instant alerts for recalls that affect you. Free forever.

Product Classification

Product Details

Model Numbers
List Number: 03P77-25
UDI-DI: 00054749000050
Lot number: N25223A
Affected States
ALL
Report Date
May 6, 2026
Recall Status
ACTIVE

Related Recalls