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U.S. Department of Health and Human Services

Class 2 Device Recall Peristaltic Head Tubing

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  Class 2 Device Recall Peristaltic Head Tubing see related information
Date Initiated by Firm September 29, 2017
Create Date November 21, 2017
Recall Status1 Completed
Recall Number Z-0166-2018
Recall Event ID 78225
510(K)Number K980367  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
Code Information Serial numbers - 125589-1-2, 125589-1-4
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Dr
Irving TX 75038-4313
For Additional Information Contact Customer Service
972-518-6001
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
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.
Quantity in Commerce 44 units
Distribution Worldwide distribution to US, Canada, France, and Germany.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = ABBOTT LABORATORIES
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