VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only.
- Company
- Bio-Rad Laboratories Inc
- Recall Initiated
- April 14, 2010
- Posted
- April 14, 2011
- Terminated
- August 8, 2011
- Recall Number
- Z-1984-2011
- Quantity
- 658 units
- Firm Location
- Hercules, CA
Reason for Recall
The affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen and Set/Test/Pattern Setting sub screen to be overwritten when the Update Kit procedure is performed.
Distribution
Worldwide Distribution -- USA , Brazil, Canada, Caribbean, France, Italy, and United Kingdom.
Lot / Code Info
Resin Update CD-ROM, 250-3020 lot # AA 00092 goes with Reorder Pack Lot No. 50392618 Resin Update CD-ROM, 250-3020 lot # BA 00092 goes with Reorder Pack Lot No 50300210. Resin Update CD-ROM, 250-3020 lot # CA 00092 Reorder Pack Lot No 50300645 & 50300650. Expiration date: 05/31/2011, 06/30/2011, 08/31/2011 PIN No. 250-3000;
Root Cause
Software design (manufacturing process)
Action Taken
Bio-Rad Laboratories sent out the Urgent Medical Device Correction notice on 4/14/2011, by Federal Express. An Update was sent on May 13th, advising customers of a minor discrepancy in the parameters included on the affected Resin Update CD-ROMs. Customers were instructed to examine your inventory for the affected reorder pack lots. Please complete and return the Medical Device Correction Response Form Questions regarding this recall please call (510) 724-6114.