Device Recall Dimension Clinical Chemistry System Wash 의 리콜

Recall

68848

Class 2

Z-2238-2014

2014-07-15

2014-08-15

Terminated

United States

2015-08-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128853

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.

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.