Abbott ARCHITECT c8000 Processing Module Recall for Potential Incorrect Results
Abbott is recalling 3,794 ARCHITECT c8000 Processing Modules because unresolved error codes may cause the instrument to generate incorrect diagnostic results.
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 involves a risk of incorrect diagnostic results, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Abbott Laboratories, Inc. is recalling 3,794 Abbott ARCHITECT c8000 Processing Modules (List No. 01G06). The recall affects instruments distributed worldwide, including the United States and numerous international markets. The product is intended for in vitro diagnostic use only and is designed to perform automated chemistry tests.
The recall is being conducted because there is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status. The ARCHITECT c4000, c8000, and c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration, but the specific issue involves the handling of error codes during status transitions.
Healthcare facilities and laboratories using these instruments should contact Abbott Laboratories for instructions on how to resolve the issue or replace the affected modules. No specific serial numbers are listed, indicating that all serial numbers for the affected list number are included in this recall.
The recalled product
- Product
- Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentio
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 3,794
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 serial numbers
Distribution
Part of a larger recall action
This product is one of 3 recalled by Abbott Laboratories, 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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