Recall Z-1495-2011 ยท JQW Station, Pipetting And Diluting, For Clinical Use
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 reduct
| Date | Mar 2, 2011 (initiated Sep 29, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software change control |
| Action | 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 instruc |
| Quantity | 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, Sweden, and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.