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Completed

ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.

FDA Recall Z-0165-2018 · Posted None

Recalling FirmAbbott Laboratories, Inc
Recall StatusCompleted
Product CodeJJE
Date Initiated2017-09-29
Product Quantity34 units

Reason for Recall

The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.

Firm Action

All worldwide ARCHITECT Clinical Chemistry System customers with impacted instruments will receive the Product Correction Letter dated, 9/29/17. A customer reply is requested from all affected consignees.

Root Cause

Component design/selection

Distribution Pattern

Worldwide distribution to US, Canada, France, and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980367AEROSET SYSTEMAbbott Laboratories · 1998-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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