Abbott i-STAT CG8+ Cartridges Recalled for Inaccurate Potassium Results
Abbott Point Of Care Inc. is recalling i-STAT CG8+ Cartridges because they may generate inaccurate potassium results, potentially leading to incorrect clinical decisions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or adverse health consequences (such as incorrect clinical decisions due to inaccurate lab results) are rated as Severe.
Plain-English summary
Abbott Point Of Care Inc. is recalling 17,550 Abbott i-STAT CG8+ Cartridges. These cartridges are intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. The specific lot number is L18059, and the affected box numbers are 0221, 0222, 0223, 0224, 0231, 0232, and 0233. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is being issued because the cartridges may generate inaccurate potassium results. Specifically, when testing with control fluid or patient samples with low or reference range potassium concentrations, the cartridges may generate elevated potassium results. Conversely, when testing with samples that have a high concentration of potassium, the cartridges may generate decreased potassium results.
The distribution pattern for these units is listed as WI. Healthcare providers and laboratories using these cartridges should stop using the affected lot and contact Abbott Point Of Care Inc. for further instructions or replacement.
The recalled product
- Product
- Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)L18059
- Manufacturer
- Abbott Point Of Care Inc.
- Hazard
- Affected units
- 17,550
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 (7)
- Lot Number: L18059 Box Numbers: 0221
- 0222
- 0223
- 0224
- 0231
- 0232
- 0233
Distribution
Distributed in 1 state:
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