The Recall Desk
HighFDA (Devices)·Z-0923-2018·Announced 2018-03-14

Abbott Recalls ARCHITECT c16000 Cuvette Segments Due to Falsely Depressed Results

Abbott Laboratories is recalling cuvette segments for the ARCHITECT Clinical Chemistry system because detached segment posts may cause falsely depressed patient test 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 component that can produce inaccurate test results, posing a risk of harm where injury has not yet been reported. This aligns with the 'risk-of-harm products where injury has not yet been reported' criterion for High severity.

Plain-English summary

Abbott Laboratories, Inc. is voluntarily recalling ARCHITECT c16000 Cuvette Segments, Part #09D32-05/ 03L77. These components are used in the ARCHITECT Clinical Chemistry Systems to perform automated chemistry tests. The recall affects all serial numbers of these cuvette segments.

The issue arises from a potential detachment of the segment post within the cuvette. This defect can generate falsely depressed patient results for any assay run on c4000, c8000, and c16000 instruments. Falsely depressed results could lead to incorrect clinical decisions regarding patient care.

The recalled products are distributed worldwide, including nationwide in the US (including Puerto Rico) and numerous other countries across multiple continents. The firm name on the label is Abbott Laboratories, Abbott Park, IL.

The recalled product

Product
ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165 cuvettes pairs or a total of 330 cuvettes (22 cuvettes x 15
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 →

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