Warning
Abbott Point Of Care Inc. Recalls i-STAT G3+ cartridge; List Number: 03P78-26;
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2001-2026Medical Device
Abbott Point Of Care Inc. Recalls i-STAT G3+ cartridge; List Number: 03P78-26;
Abbott Point Of Care Inc. · Class II — Moderate Risk
Product Description
i-STAT G3+ cartridge; List Number: 03P78-26;
Reason for Recall
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database