i-STAT CG8+ Cartridge recallZ-0929-2011 · Abbott Point of Care Inc. · initiated Aug 3, 2010
Terminated All recalls posted in January 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
Two cartridge lots were identified that may generate falsely elevated PCO2 results.
FDA root cause category: Other
What the company is doing
Abbott Point of Care Inc. sent an Urgent Recall Notice letter dated July 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the cartridges from the identified lots and follow the instructions on the enclosed reply card to receive replacement cartridges. If cartridges were distributed from the lot numbers to another institution, a copy of the recall letter should be provided to them. For any questions regarding this recall contact Abbott-Point of Care Technical Support at 800-366-8020, Option 1.
Recall details
- Recall number
- Z-0929-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 3, 2010
- Posted by the FDA
- Jan 20, 2011
- Recalling firm
- Abbott Point of Care Inc.
- Quantity
- 55350 total cartridges
- Product code
- CHL
- FDA submissions
- K940918
- Distribution
- Worldwide Distribution - USA including AL, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY and the countries of Oman and Turkey.
Product description
i-STAT CG8+ Cartridge; pH, pCO2, PO2, NA, K, iCa, Glu, Hct; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the 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)
List number 03M86-01, 03M86-02, lot number T10036A
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
Other products in the same recall event
The FDA groups related products into one recall event (event 56403).
- Z-0930-2011 · Terminatedi-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide pa…
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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