The Recall Desk
HighFDA (Devices)·Z-0921-2018·Announced 2018-03-14

Abbott ARCHITECT c4000 Cuvette Segment Recall for Potential False Results

Abbott is recalling ARCHITECT c4000 Cuvette Segments because a detached post can 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 (falsely depressed patient results) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Abbott Laboratories, Inc. is recalling the ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24. This component is a rack that holds cuvettes for the ARCHITECT Clinical Chemistry system. The recall involves 3,634 ARCHITECT c4000 systems distributed worldwide, including the United States and Puerto Rico.

The recall is due to a potential issue where a detached segment post can generate falsely depressed patient results in the cuvettes adjacent to the post. This risk applies to any assay run on the c4000, c8000, and c16000 instruments. The hazard is a diagnostic error rather than a direct physical injury.

Healthcare facilities and laboratories should stop using the affected cuvette segments and contact Abbott for instructions on replacement or repair. The recall covers all serial numbers of the affected component.

The recalled product

Product
ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories,
Manufacturer
Abbott Laboratories, Inc
Category
Medical Device — Clinical Chemistry Component
Hazard

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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 3 products in this recall →

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