Abbott ARCHITECT c4000 Cuvette Segment Recall for Potential False Results
Abbott is recalling 1,385 ARCHITECT c4000 cuvette segments because a detached post may cause falsely depressed patient results in adjacent cuvettes.
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, but the hazard (falsely depressed patient results) could lead to incorrect clinical decisions.
Plain-English summary
Abbott Laboratories, Inc. is recalling 1,385 ARCHITECT c4000 Cuvette Segments (List number 02P75-01). These segments are components of the ARCHITECT c4000 system, which is intended for in vitro diagnostic use to perform automated chemistry tests. The segments are racks that sit in the reaction carousel and hold cuvettes.
The recall is due to a potential for a segment post to detach. If this occurs, there is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.
The affected units were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous countries across Africa, Asia, Europe, the Middle East, and the Americas. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuv
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 1,385
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 c4000s
Distribution
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