The Recall Desk
ModerateFDA (Devices)·Z-0761-2020·Announced 2020-01-08

Abbott i-STAT cTnI Cartridges Recalled for Quality Check Code Issues

Abbott Point Of Care Inc. is recalling i-STAT cTnI cartridges because they may generate a higher than expected number of quality check codes.

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 involves quality check codes rather than direct patient injury or death, and no illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Abbott Point Of Care Inc. is recalling i-STAT cTnI cartridges. The recall involves 3,465,875 units distributed across 32 U.S. states and the District of Columbia. The specific list numbers are 06P23-25 and the UDI is (01)00054749001986.

The recall was initiated because the cartridges may generate a higher than expected number of quality check codes. The observed rate of these quality check codes could be in the 3 to 5% range. This issue may affect the reliability of the quality control process for the device.

Consumers and healthcare facilities should stop using the affected i-STAT cTnI cartridges and contact Abbott Point Of Care Inc. for further instructions or a replacement. The recall is classified as Class II by the FDA.

The recalled product

Product
i-STAT cTnI cartridge
Manufacturer
Abbott Point Of Care Inc.
Category
Medical Device — Point-of-Care Testing
Hazard
Affected units
3,465,875

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)

  • List Number: 06P23-25 UDI: (01)00054749001986

Distribution

Distributed in 34 states:

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