Bio-Rad Laboratories Inc PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD System. Manufactured by Bio-Rad Laboratories, France, Distributed by Bio-Rad Laboratories, Hercules, CA. EIA and IFA processing system that consists of a PhD fluid handling station (s) linked to a network computer via ethernet hub. The computer provides worklist generation, data management, data reduction and microplate reader control functions. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD System. Manufactured by Bio-Rad Laboratories, France, Distributed by Bio-Rad Laboratories, Hercules, CA. EIA and IFA processing system that consists of a PhD fluid handling station (s) linked to a network computer via ethernet hub. The computer provides worklist generation, data management, data reduction and microplate reader control functions.
Brand
Bio-Rad Laboratories Inc
Lot Codes / Batch Numbers
Model 426-0246, software version 2.1A
Products Sold
Model 426-0246, software version 2.1A
Bio-Rad Laboratories Inc is recalling PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD Syste due to Incorrect patient results are being generated from out-of-range samples tested withc ompetitive enzyme immunoassays on the PhD system with software ve. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CO, CT, FL, IL, MD, MA, MN, MS, MO, MT, NY, NC, OH, PA, SD, TN, TX, UT, VT, DC
Page updated: Jan 10, 2026