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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Sirolimus (SIRO) Flex reagent cartridge

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  Class 2 Device Recall Dimension Sirolimus (SIRO) Flex reagent cartridge see related information
Date Initiated by Firm February 09, 2016
Create Date May 10, 2016
Recall Status1 Terminated 3 on June 12, 2018
Recall Number Z-1633-2016
Recall Event ID 73442
510(K)Number K081857  
Product Classification Sirolimus test system - Product Code NRP
Product Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability

The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.
Code Information Lot # EB6064
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Richard Anderson
302-631-0528
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by the Customer: Discontinue use of and discard the kit lot listed in Table 1. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (302) 631-0528.
Quantity in Commerce 394
Distribution Worldwide distribution and US including Puerto Rico and to the states of : TX, FL, CA, LA, DC, GA, IL, AR, WI, MI and MD.
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 = NRP and Original Applicant = Siemens Healthcare Diagnostics Inc.
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