The Recall Desk
ModerateFDA (Devices)·Z-0880-2021·Announced 2021-01-27

Abbott i-STAT CG8+ Cartridges Recalled for Ionized Calcium Test Inaccuracy

Abbott is recalling i-STAT CG8+ cartridges because the ionized calcium test may report higher than expected results if stored at room temperature for specific periods.

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, and the hazard involves potential diagnostic inaccuracy without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Abbott Point Of Care Inc. is recalling approximately 2,820,000 i-STAT CG8+ cartridges in the United States and 2,273,453 cartridges outside the United States. The recall is due to a potential inaccuracy in the ionized calcium test, which may exhibit higher than expected reported results under specific storage conditions.

The affected cartridges are intended for the quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2, and hematocrit in venous, arterial, or capillary whole blood. The issue occurs when the cartridges are stored at room temperature (18 to 30°C) for periods exceeding 3 days for lot numbers *20100 to *20339, or 7 days for lot numbers *20340 and above, where the lot letter is A, K, L, M, N, W, or Y.

The recall is distributed nationwide. Users should check their inventory for the affected lot numbers and storage conditions. If the cartridges have been stored at room temperature for the specified durations, they should be removed from use to prevent potential diagnostic errors.

The recalled product

Product
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
Manufacturer
Abbott Point Of Care Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard

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 (5)

  • K
  • L
  • M
  • N
  • W or Y Primary GTIN (01) 00054749000163)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Abbott Point Of Care Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Abbott Point Of Care Inc.

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Same hazard · diagnostic inaccuracy

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