PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD System. Manufactured by B

FDA device recall Z-1495-2011 · posted 2011-03-02 · Terminated

Recall details

Recalling firm

Bio-Rad Laboratories Inc

Reason for recall

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.

Action taken

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.

Root cause

Software change control

Status

Terminated

Product code

JQW

Quantity affected

262 units

Distribution

Worldwide Distribution - USA including AL, CA, CO, CT, DC, FL, IL, MA, MD, MN, MO, MS, MT, NC, NY, OH, PA, SD, TN, TX, UT, and VT and the countries of Australia, New Zealand, Singapore, China, France,

Date initiated

2009-09-29

Date posted

2011-03-02

Date terminated

2011-03-11

Location

Hercules, CA