Lower risk Medical device recall · FDA · Published January 15, 2020

Abbott i-STAT CG4+ Blue Cartridge Recall: Not FDA Cleared for CLIA Waived Tests

Abbott recalls i-STAT CG4+ blue cartridges (List No. 03P85-50) as they are not FDA cleared and lack CLIA waived status, risking improper lab testing.

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

🇺🇸 FDA recall #Z-1263-2020Medical device Abbott ›

Lower-risk recall

The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for venous whole blood samples, meaning this cartridge could be used in a facility with a CLIA Certificate of Waiver as a waived test.

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 CG4+ blue cartridges because they are not FDA cleared and do not have CLIA waived status. This means they cannot be legally used in labs that require waived tests, potentially leading to incorrect medical results. Read more at govinfonow.com/recall/65993-abbott-i-stat-cg4-blue-cartridge-recall-not-fda-cleared.

Source Summary by GovInfoNow · govinfonow.com/recall/65993-abbott-i-stat-cg4-blue-cartridge-recall-not-fda-cleared · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1263-2020

Cite this page

“Abbott i-STAT CG4+ Blue Cartridge Recall: Not FDA Cleared for CLIA Waived Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65993-abbott-i-stat-cg4-blue-cartridge-recall-not-fda-cleared. Based on FDA recall #Z-1263-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1263-2020%22&limit=1).

The FDA announced on Jan. 15, 2020, that Abbott Point Of Care Inc. is recalling i-STAT CG4+ cartridges because they lack FDA clearance and CLIA waived status. The agency classified the recall as Class II.

How to tell if you have it

i-STAT CG4+ cartridge (blue), List No. 03P85-50
UDI (01) 00054749002269
UPC 00054749002269

The hazard

According to the FDA, the i-STAT CG4+ cartridges are not FDA cleared and do not have CLIA waived status. This means they cannot be used in facilities with a CLIA Certificate of Waiver as intended for waived tests.

Context

GovInfoNow's records show Abbott Point Of Care Inc. has had 8 other recalls since Sept. 12, 2017. Other recent recalls include the Abbott i-STAT G3+ Cartridges recall on April 1, 2026, and the Abbott i-STAT EG7+ Cartridge Recall on Aug. 21, 2025. Similar products recalled recently include the QUCARE Total Cholesterol Test on April 2, 2026, and the Bisaf Strep A Self-Test on Dec. 19, 2025.

How to tell if you have this one

Check for the blue i-STAT CG4+ cartridge with List No. 03P85-50 and UDI (01) 00054749002269. All lots of this product are affected.

Brand
Abbott
Product
i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269
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
US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-1262-2020	i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine, and hematocrit in venous, arterial or capillary whole blood.; All lots are affected	9,049,725
Z-1263-2020	i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous, arterial or capillary whole blood.; All lots are affected	99,850

Based on the official FDA remedy

What to do — step by step

Check Cartridge Details
Identify the blue i-STAT CG4+ cartridge with List No. 03P85-50 and UDI (01) 00054749002269.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

Jan 15, 2020Firm started the recall
Feb 18, 2020FDA classified it Class II
Feb 26, 2020Published in FDA’s Enforcement Report
Mar 2, 2021FDA terminated the recall

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

Similar recalls

Latest medical device recalls

Keep exploring

More Abbott recalls

Link to this recall

<a href="https://govinfonow.com/recall/65993-abbott-i-stat-cg4-blue-cartridge-recall-not-fda-cleared">Abbott i-STAT CG4+ Blue Cartridge Recall: Not FDA Cleared for CLIA Waived Tests (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-1263-2020 (January 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1263-2020 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.