Lower risk Medical device recall · FDA · Published December 22, 2020

Abbott i-STAT CG8+ Cartridges May Give Higher Calcium Results If Stored Too Long

Abbott recalls i-STAT CG8+ cartridges that may show higher than expected calcium results when stored at room temperature for more than 3 days (lots *20100-*20339) or 7 days (lots *20340+).

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0880-2021Medical device Abbott ›

Lower-risk recall

Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.

Take action

Contact the company

Recalling firmAbbott Point Of Care Inc.400 College Rd E · Princeton, NJ 08540-6607

✎ GovInfoNow plain-language explainer

Abbott is recalling i-STAT CG8+ cartridges that may give higher than expected calcium test results if stored at room temperature for more than 3 days (for certain lots) or 7 days (for other lots). This could lead to inaccurate test results if used after the storage period. Read more at govinfonow.com/recall/63623-abbott-i-stat-cg8-cartridges-may-give-higher-calcium-results.

Source Summary by GovInfoNow · govinfonow.com/recall/63623-abbott-i-stat-cg8-cartridges-may-give-higher-calcium-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0880-2021

Cite this page

“Abbott i-STAT CG8+ Cartridges May Give Higher Calcium Results If Stored Too Long.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63623-abbott-i-stat-cg8-cartridges-may-give-higher-calcium-results. Based on FDA recall #Z-0880-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0880-2021%22&limit=1).

Abbott Point Of Care Inc. recalled Abbott i-STAT CG8+ cartridges on Dec. 22, 2020, because ionized calcium tests may show higher than expected results when stored at room temperature for too long, the FDA said. Owners should contact the company for a refund.

How to tell if you have it

Brand: Abbott
Product: i-STAT CG8+ cartridges
Lot numbers: *20100 to *20339 and *20340 and above (where * = A, K, L, M, N, W or Y)
GTIN: 00054749000163

The hazard

The hazard is that ionized calcium tests on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above.

Context

GovInfoNow's records show Abbott Point Of Care Inc. has had 8 other recalls on record since Sept. 12, 2017. Other recent recalls include Abbott i-STAT G3+ Cartridges May Show Wrong Blood Gas Results (April 1, 2026), Abbott i-STAT CG4+ Cartridge Recall: Lack of Premarket Clearance (Aug. 21, 2025) and Abbott i-STAT EG7+ Cartridge Recall: Lack of Premarket Clearance (Aug. 21, 2025).

How to tell if you have this one

Check the lot number on the cartridge packaging. The lot numbers range from *20100 to *20339 (for storage up to 3 days) and *20340 and above (for storage up to 7 days). The * symbol represents lot letters A, K, L, M, N, W, or Y.

Brand
Abbott
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide

Recall number	Product, codes & lots	Quantity
Z-0880-2021	Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25; Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers 20100 to 20339 7 days for lot numbers 20340 and above Where = lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163)	2,820,000 cartridges US and 2,273,453 catridges OUS
Z-0881-2021	Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25; Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers 20100 to 20339 7 days for lot numbers 20340 and above Where = lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163)	1,521,800 cartridges US and 2,641,053 cartridges OUS

Based on the official FDA remedy

What to do — step by step

Check Storage Period
Verify if the cartridge has been stored at room temperature for more than the recommended time (3 days for lots *20100 to *20339 or 7 days for lots *20340 and above).

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

Dec 22, 2020Firm started the recall
Jan 19, 2021FDA classified it Class II
Jan 27, 2021Published in FDA’s Enforcement Report
Sep 1, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63623-abbott-i-stat-cg8-cartridges-may-give-higher-calcium-results">Abbott i-STAT CG8+ Cartridges May Give Higher Calcium Results If Stored Too Long (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0880-2021 (December 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0880-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.