Device Recall Roche / Hitachi MODULAR Analytics Combination System 의 리콜

Recall

79074

Class 2

Z-1269-2018

2017-12-18

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161279

Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.

Roche Diagnostics Corporation issued Urgent Medical Device Correction (UMDC) notices and Fax Forms to their customers dated 12/18/2017 via UPS Ground (receipt required). Customers are encouraged to do the following Mandatory Steps to improve the vertical alignment and handling of 13 mm sample tubes and false bottom tubes: FOR cobas e 411 & cobas e 601 analyzers and MODULAR ANALYTICS E 170 module: 1) Always use Roche rack cup adapters with 13 mm tubes 2) Ensure sample tubes are straight FOR cobas e 411 disk system: 1) Always use 13 mm Sample Disk Tube Adapters (SDTAs) with 13 mm sample tubes. 2) Ensure sample tubes are straight. 3) Ensure 13 mm SDTAs are not exposed to direct sunlight. 4) If a larger diameter tube is left inserted in a 13 mm SDTA for more than 3 days, the adapter may become distorted. Do not insert smaller diameter tubes into distorted adapter as they may not align correctly. **All customers are encouraged to DISCARD Analyzer Bulletin 10-009U3. Follow the care and handling instructions for using adapters as outlined in this Urgent Medical Device Correction (UMDC) and complete & return the UMDC fax form via fax to 1-877-271-1472