Abbott ARCHITECT c16000 Processing Module Recalled for Potential Incorrect Results
Abbott Laboratories is recalling 1,666 ARCHITECT c16000 Processing Modules worldwide 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 medical device where a defect could lead to incorrect diagnostic results, representing a risk of harm to patients through misdiagnosis or treatment errors, even though no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Abbott Laboratories, Inc. is recalling 1,666 units of the Abbott ARCHITECT c16000 Processing Module (List No. 03L77) worldwide. The recall covers instruments distributed in the United States and numerous international locations, including Canada, the United Kingdom, Australia, and various countries in Europe, Asia, Africa, and the Americas. The recall applies to all serial numbers of the affected product.
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 Abbott ARCHITECT System is intended for In Vitro diagnostic use only and is designed to perform automated chemistry tests utilizing photometry and potentiometric technology. The sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.
Healthcare facilities and laboratories using these instruments should contact Abbott Laboratories for instructions on how to resolve the issue and ensure accurate diagnostic testing.
The recalled product
- Product
- Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - 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 potenti
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 1,666
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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