PhD System EIA/IFAversion 2.1A software 의 리콜

Recall

53690

Class 3

Z-1495-2011

2011-03-02

Terminated

United States

2011-03-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86329

Incorrect patient results are being generated from out-of-range samples tested withc ompetitive enzyme immunoassays on the phd system with software version 2.1a.

BIO-RAD sent an URGENT: MEDICAL DEVICE CORRECTION letter dated September 29, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their customer records to identify all PhD System customers that are using version 2.1A of the EIA/IFA Software and Methods CD-ROM. Customers who are not running competitive immunoassays on the PhD System may continue using the 2.1A software. Customers who run competitive immunoassays must revert to software version 2.0B. Customers were instructed to translate if necessary and add local contact information to the customer letter and distribute to all PhD System customers that are using 2.1A of the EIA/IFA Software and Methods CD-ROM. A Customer Medical Device Correction Response Form must be collected from each customer to ensure that they have received this important communication. Once forms have been collected from all applicable customers, they should be faxed to Bio-Rad CSD Regulatory Affairs Department along with the completed Subsidiary Medical Device Correction Response Form. For questions regarding this recall call 510-741-3954.