VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufacture
FDA device recall Z-1984-2011 · posted 2011-04-14 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- 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.
- 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.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- GKA
- Quantity affected
- 658 units
- Distribution
- Worldwide Distribution -- USA , Brazil, Canada, Caribbean, France, Italy, and United Kingdom.
- Date initiated
- 2010-04-14
- Date posted
- 2011-04-14
- Date terminated
- 2011-08-08
- Location
- Hercules, CA
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