United Statesi-STAT EG7+ (List Number 03P76-25, UDI‑DI 00054749000043; lots N25206, N25207, N25209, N25213, N25218, N25219, N25233), i-STAT EG6+ (List Number 03P77-25, UDI‑DI 00054749000050; lot N25223A) and i-STAT G3+ (List Number 03P78-26, UDI‑DI 00054749005673; lot N25221) cartridges are being recalled. Approximately 7.6% of cartridges from these lots may report higher than expected PCO2 and lower than expected pH due to a manufacturing issue, which can make a blood gas appear as severe respiratory acidosis and could lead clinicians to unnecessary or harmful interventions.
What's being recalled
i-STAT EG7+ cartridge; List Number: 03P76-25;
i-STAT EG6+ cartridge; List Number: 03P77-25;
i-STAT G3+ cartridge; List Number: 03P78-26;
Recalling firm: Abbott Point Of Care Inc., Princeton, NJ, United States.
How to identify it
List Number: 03P76-25; UDI-DI: 00054749000043; Lot numbers: N25206, N25207, N25209, N25213, N25218, N25219, N25233; List Number: 03P77-25; UDI-DI: 00054749000050; Lot number: N25223A; List Number: 03P78-26; UDI-DI: 00054749005673; Lot number: N25221;
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada