Abbott i-STAT EG7+ Cartridges Recalled for Ionized Calcium Test Inaccuracy
Abbott Point Of Care Inc. is recalling i-STAT EG7+ 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
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Abbott Point Of Care Inc. is recalling the i-STAT EG7+ cartridge-IVD, intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2, and hematocrit in whole blood. The recall affects 1,521,800 cartridges in the US and 2,641,053 cartridges outside the US, distributed nationwide.
The recall is due to the ionized calcium test on some i-STAT CG8+ and EG7+ cartridges potentially exhibiting higher than expected reported results. This 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. The asterisk (*) represents lot letters A, K, L, M, N, W, or Y.
Healthcare facilities and users should check their inventory for the affected lot numbers and storage conditions. The agency has classified this as a Class II recall.
The recalled product
- Product
- 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
- Manufacturer
- Abbott Point Of Care Inc.
- 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.
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