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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01501-1
Product Name/Description Architect c4000, c8000, c16000 Cuvette Segment. An in vitro diagnostic medical device (IVD)

List Number: 02P75-01, 01G46-01, 09D32-05

ARTG Number: 199356
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 18/12/2017
Responsible Entity Abbott Australasia Pty Ltd Diagnostic Division
Reason/Issue The base of the ARCHITECT Cuvette Segment may become detached under specific conditions. When a segment base is detached, cuvettes may be seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom.

Reasons for the bottom of the cuvette segment to detach are
• Excessive force applied during manual cleaning of cuvettes or cuvette wash tower crashes
• Lack of sufficient glue during cuvette segment manufacturing (c4000 and c8000 only)

If a segment is detached, 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 instrument. Falsely depressed results may or may not be accompanied by a result flag.
Recall Action Recall for Product Correction
Recall Action Instructions Impacted patient results may be accompanied by “<” or “LOW” result flags, indicating that the result is below the linear range or the defined normal range of the assay, respectively. See ARCHITECT System Operations Manual Section 5: Operating Instructions for more information on patient result flags.
Abbott is providing users with new instructions to avoid damaging the cuvette segments.

A review of previously generated patient results is at the discretion of the Laboratory Manager,

This action has been closed out on 15/11/2018
Contact Information 1800 816 696 - Abbott Customer Care