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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica IM 1300 Analyzer

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  Class 2 Device Recall Atellica IM 1300 Analyzer see related information
Date Initiated by Firm March 07, 2019
Create Date May 09, 2019
Recall Status1 Terminated 3 on August 20, 2020
Recall Number Z-1299-2019
Recall Event ID 82602
510(K)Number K151792  
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
Product Atellica IM 1300 Analyzer, Material Number 11066001
Code Information UDI: 00630414007960
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Gene Victori
914-631-8000
Manufacturer Reason
for Recall		 There were multiple issues identified in the system software which required an update.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Correction notification letters dated 3/7/19 were sent to customers.
Quantity in Commerce 277
Distribution The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Pakistan, Poland, Portugal Republic of Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, and Vietnam.
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.
510(K) Database 510(K)s with Product Code = JLW and Original Applicant = Siemens Healthcare Diagnostics,Inc.
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