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High RiskFDAfda-Z-2133-2012OTHER

I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure ...

Units Affected
52,750
Recall Date
January 1, 2011
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2133-2012.

i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2133-2012.

Recall terminated by FDA.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2133-2012.

Abbott Point Of Care Inc.

FDA

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

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Abbott Point Of Care Inc. Recall FAQ

Abbott Point Of Care Inc. is the subject of a respiratory devices safety report: I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure .... The notice was published on January 1, 2011 by the U.S. Food and Drug Administration (FDA). Approximately 52,750 units are potentially affected.