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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT Instrument

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  Class 2 Device Recall ARCHITECT Instrument see related information
Date Initiated by Firm September 29, 2017
Create Date November 21, 2017
Recall Status1 Completed
Recall Number Z-0165-2018
Recall Event ID 78225
510(K)Number K980367  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
Code Information c400073, c400103, c400498, c400600, c400890, c400934, c400935, c401018, c401055, c401056, c401182, c401505, c401520, c401686, c401887, c460196, c460200, c460943, c461550, c803669, c803753, c1600144, c1600249, c1600251, c1600641, c1600720, c1600819, c1600859, c1600976, c1601350, c1601351
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 34 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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