Abbott i-STAT DE Handheld Module Software Update Recall
Abbott Point Of Care Inc. is recalling 894 i-STAT DE handheld data processing modules because a software upgrade resets customized settings and prevents certain data from updating.
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 2/5 (Moderate).
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 source text explicitly states that no erroneous results are generated, and the issues are limited to data management and settings resets rather than direct patient harm, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Abbott Point Of Care Inc. is recalling 894 i-STAT DE handheld data processing modules for clinical use, specifically those upgraded to Software Version 2.8. The recall affects units with List Number 08K46-01115200 and UDI 00054749001255.
The recall was initiated because the software upgrade causes two specific issues: location, operator, and stored patient lists do not update, and customized reference ranges, action ranges, and custom reportable ranges are reset to factory default values. The source text explicitly states that no erroneous results are generated as a result of this issue.
The affected units were distributed in 48 states, the District of Columbia, Australia, Italy, Sweden, and Canada. Users of these devices should contact Abbott Point Of Care Inc. for further instructions on how to address the software configuration issues.
The recalled product
- Product
- i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
- Manufacturer
- Abbott Point Of Care Inc.
- Affected units
- 894
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)
- All units that have been upgraded to software version 2.8
Distribution
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