i-STAT G3+ Cartridge: PCO2 recallZ-1621-2011 · Abbott Point Of Care Inc. · initiated Sep 25, 2006
Terminated All recalls posted in March 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Point Of Care Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Certain lots of G3+ cartridges may be difficult to fill.
FDA root cause category: Other
What the company is doing
The firm, Abbott Point of Care, sent a "Important notice" letter dated September 25, 2006 to all customers. The letter described the product, problem and actions to be taken. The customers were to destroy and discard the i-STAT G3+ Cartridges and complete and return the customer reply form. Abbott sent replacements cartridges to their customers. If you or any of the healthcare providers you serve have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1.
Recall details
- Recall number
- Z-1621-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 25, 2006
- Posted by the FDA
- Mar 10, 2011
- Recalling firm
- Abbott Point Of Care Inc.
- Quantity
- 12,675 in US, 125 ROW
- Product code
- CHL
- FDA submissions
- K940918
- Distribution
- Worldwide distribution: USA and country of : Canada.
Product description
i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeton, NJ 08540 The test for PCO2, as part of the i-STAT System, is intended for use in the in vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance.
Code information (models, lots, serial numbers)
Catalog number: 06F03-1, 06F03-02; Lot numbers: J06072, Exp 10/28/2006; J06076, Exp 11/14/2006; J06081, Exp 11/14/2006; J06083, Exp 11/14/2006; J06085, Exp 11/14/2006.
Other devices under the same FDA submission
5 devices cleared under K940918 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- i-STAT 03P88-25Abbott Point Of Care Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH105 reports
- i-STAT 03P76-25Abbott Point Of Care Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH1 recall46 reports
- i-STAT 03P77-25Abbott Point Of Care Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH1 recall10 reports
- i-STAT 03P79-25Abbott Point Of Care Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH23 reports
- i-STAT 03P78-25Abbott Point Of Care Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH16 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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