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U.S. Department of Health and Human Services

Class 2 Device Recall Hettich Centrifuge Module

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  Class 2 Device Recall Hettich Centrifuge Module see related information
Date Initiated by Firm May 11, 2016
Create Date June 29, 2016
Recall Status1 Terminated 3 on April 27, 2018
Recall Number Z-2087-2016
Recall Event ID 74280
Product Classification Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
Product Hettich Centrifuge Modules:
StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836)
Aptio Centrifuge Module (10703032 or 10713761)
FlexLab High Throughput Centrifuge Module (11171747)
FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities.
Code Information All serial numbers are affected.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc.
101 Silvermine Rd
Brookfield CT 06804-2047
For Additional Information Contact Anne Murphy
203-740-6404
Manufacturer Reason
for Recall		 Premature bucket failures
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens mailed to customers an Urgent Medical Device Correction (UMDC#LAI16-02.A.US) Urgent Field Safety Notification letter informing customers of the problem with recommendations to follow the existing maintenance instructions in the product operator manuals as well as a new requirement to spin at cycle speeds not exceeding 3500 rpm.
Quantity in Commerce 487
Distribution Nationwide: AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV.
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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