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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Dimension LOCI High sensitivity Troponin I (TNIH) assay

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  Class 2 Device Recall Siemens Dimension LOCI High sensitivity Troponin I (TNIH) assay see related information
Date Initiated by Firm August 19, 2020
Create Date October 02, 2020
Recall Status1 Terminated 3 on August 25, 2023
Recall Number Z-0052-2021
Recall Event ID 86374
510(K)Number K190675  
Product Classification Immunoassay method, troponin subunit - Product Code MMI
Product Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the
quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
Code Information Lot # EB0255 UDI: 00842768037726EB025520091110471068840
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr
Newark DE 19702-2466
For Additional Information Contact SAME
800-441-9250
Manufacturer Reason
for Recall		 Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens issued Urgent Medical Device Correction (UMDC # VC-20-03.B.US) and Urgent Field Safety Notice (UFSN # VC-20-03.B.OUS) issued on August 19, 2020 via FedX to US Dimension customers who received the Dimension TNIH reagent lot to notify them of the issue, the risk to health, and the following actions to be taken by the customer: Review the letter with their Medical Director"If they are using TNIH lot EB0255 DO NOT switch to another TNIH lot during serial measurements for a single patient sample. Discontinue use and discard the TNIH reagent lot EB0255 upon receipt of replacement product. Request your no-charge replacement for lot EB0255. Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. Questions, contact your Siemens Remote Services Center or your local Siemens Technical Support representative.
Quantity in Commerce 533 US and 1822 OUS
Distribution US Nationwide distribution.
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 = MMI and Original Applicant = Siemens Healthcare Diagnostics, Inc.
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