The Recall Desk
ModerateFDA (Devices)·Z-1265-2020·Announced 2020-02-26

Abbott i-STAT G3+ Cartridge Recalled for Lack of Clinical Evidence

Abbott Point of Care is recalling i-STAT G3+ blue cartridges because it lacks sufficient clinical evidence to characterize their performance.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a regulatory and performance uncertainty (lack of clinical evidence) rather than a reported injury or specific physical defect, fitting the Moderate criteria for voluntary precautionary actions.

Plain-English summary

Abbott Point of Care Inc. is recalling the i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (00054749002283). The product is used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial, or capillary whole blood. A total of 4,448,525 units were distributed nationwide in the United States.

The recall was initiated because the product was marketed without a 510(k) clearance. Abbott Point of Care determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges. As a result, the company will no longer distribute these cartridges in the United States as of May 1, 2020.

All lots are affected. Users should stop using the product and contact Abbott Point of Care for further instructions.

The recalled product

Product
i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole blood.
Manufacturer
Abbott Point Of Care Inc.
Category
Medical Device — Diagnostic Cartridge
Hazard
Affected units
4,448,525

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots are affected

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Abbott Point Of Care Inc.

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