FDAClass IIDecember 26, 2018

Abbott i-STAT CG8+ Cartridges intended for use in the recall

Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List…

Why was Abbott i-STAT CG8+ Cartridges intended for use in the recalled?

Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. When testing with samples with a high concentration of potassium, decreased potassium results may be generated

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: L18059 Box Numbers: 0221, 0222, 0223, 0224, 0231, 0232, 0233

Product
Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List…
Recalling firm
Abbott Point Of Care Inc.
Quantity
17550 cartridges
Distribution
WI
Recall date
December 26, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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