Device Recall S2 Fluid Pack as a part of the cobas b221 Roche OMNI S systems 의 리콜

Recall

71609

Class 2

Z-2330-2015

2015-06-24

2015-08-05

Terminated

United States

2016-01-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138377

The affected s2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. the error prevents the fluid from being recognized by the system and the instrument cannot start measurements until the affected s2 fluid pack is replaced.

Roche Diagnostics sent an Urgent Medical Device Correction dated July 2, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to do the following: 1. Keep in the inventory a backup S2 Fluid Packs from an unaffected lot, or at least four additional S2 Fluid Packs from the affected lots when product from unaffected lots is not available. 2. If the S2 Fluid Pack generates a Transponder error message, contact the Roche Support Network Customer Support Center at 1-800-526-2272 (provide the lot and serial number printed on the side of the affected S2 Fluid Pack). 3. After contacting Roche Support Network Customer Support Center, dispose of the affected S2 Fluid Pack per local guidelines. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272, if you have questions about the information contained in this Urgent Medical Device Correction.