Abbott ARCHITECT c4000 Processing Module Recalled for Potential Incorrect Results
Abbott Laboratories is recalling 3,675 ARCHITECT c4000 Processing Modules because specific 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-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Abbott Laboratories, Inc. is recalling 3,675 units of the Abbott ARCHITECT c4000 Processing Module (List No. 02P24). The recall covers all serial numbers and includes instruments distributed worldwide, including the United States and numerous international markets.
The recall is issued 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.
Healthcare facilities and laboratories that possess these instruments should contact Abbott Laboratories for further instructions on how to resolve the issue and ensure accurate diagnostic testing.
The recalled product
- Product
- Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - 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
- 3,675
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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