The Recall Desk
HighFDA (Devices)·Z-0922-2018·Announced 2018-03-14

Abbott ARCHITECT c8000 Cuvette Segment Recall for False Test Results

Abbott is recalling ARCHITECT c8000 Cuvette Segments because a detached post can cause falsely depressed patient results on c4000, c8000, and c16000 instruments.

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 is classified as FDA Class II and 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 c8000 Cuvette Segment, Part #01G46-01/01G06. This component is used in the ARCHITECT Clinical Chemistry system to hold cuvettes in the reaction carousel. The recall covers 3,357 ARCHITECT c8000 Systems distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international countries.

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 source text does not specify a particular lot number or serial number range, indicating that all serial numbers may be affected.

Healthcare facilities and users of these systems should stop using the affected cuvette segments and contact Abbott Laboratories for further instructions on replacement or repair. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvette segment holding 15 cuvettes for a total of 165 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratorie
Manufacturer
Abbott Laboratories, Inc
Category
Medical Device — Clinical Chemistry System 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 →

Related recalls

Same manufacturer · Abbott Laboratories, Inc

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Same hazard · false test results

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