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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Clinical Chemistry System Wash

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  Class 2 Device Recall Dimension Clinical Chemistry System Wash see related information
Date Initiated by Firm July 15, 2014
Date Posted August 15, 2014
Recall Status1 Terminated 3 on August 26, 2015
Recall Number Z-2238-2014
Recall Event ID 68848
510(K)Number K963498  
Product Classification Radioimmunoassay (two-site solid phase), ferritin - Product Code JMG
Product Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
Code Information lot RD41041, exp. 10/13/2014
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension® Chemistry Wash lot RD41041. Internal inv
FDA Determined
Cause 2		 Material/Component Contamination
Action Siemens sent an Urgent Medical Device Recall letter dated July 2014, 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: 1. Immediately discontinue use and discard all inventory of Chemistry Wash lot RD41041. If this lot was never in use on the instrument, no further action is needed. If this lot has been in use, continue with steps 2 through 5. 2. Place an alternate lot of Chemistry Wash on the Dimension system. 3. Prime the new bottle of Chemistry Wash 30 times. 4. Recalibrate the CTNI, LTNI, TSH, FT4, PBNP and/or LPBN assays using the alternate lot of Chemistry Wash on board. 5. For the listed assays, process Quality Control every 8 hours. Actions to be taken by Siemens: Your Customer Service Engineer will be making a visit to decontaminate the system if you have used lot RD41041. This process will take approximately two hours. Once decontamination has been completed, process and evaluate quality control. Resume routine QC testing frequency according to your standard laboratory practice. Siemens is shipping replacement product at no charge for all orders filled with lot RD41041. If you have questions about your replacement shipment, please contact Customer Service at (888) 588-3916. Please complete the attached form and fax it to (302) 631-8467 to indicate that you have received this information. Please retain this letter with your laboratory records. Please forward this letter to anyone to whom you may have provided this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in Commerce 3200
Distribution USA (nationwide) Distribution and Internationally to Canada.
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 = JMG and Original Applicant = DADE CHEMISTRY SYSTEMS, INC.
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