Recall Z-1208-2022 ยท GKA Abnormal Hemoglobin Quantitation
Bio-Rad Laboratories, Inc.
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
| Date | Apr 7, 2022 |
| Status | Open, Classified |
| Reason | The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. This CD-ROM software included in specific lots of VARIANT nbs Sickle Cell Progam Reorder Pack causes all customized settings in the Setup/Test/Data Setup subscreen and Setup/Test/Pattern Setting subscreen to be overwritten with the default settings when the Update Kit procedure is performed.The VARIANTnbs Sickle Cell Program has been validated using the default Resin Update CDROM parameters for the intended use. |
| Root cause | Packaging process control |
| Action | On 04/07/22, Field Action Notifications were sent to customers, who were informed of the following. Not affected by this action if A) affected Resin Update CD-ROM was not installed. B) Default settings are used (i.e., did not edit any settings) in the Setup/Test/Data Setup and/or Pattern Setting subscreens prior to performing the Update Kit procedure using one of the affected CD-ROMs. Affected by this action if customized settings were used and subsequently the Update Kit procedure using one of the affected CD-ROMs was performed; your customized settings were overwritten by the default Bio-Rad |
| Quantity | 1893 |
| Distribution | US: AZ, AR, GA, CO, TN, LA, VA, FL, KY, IN, KS, MD, MN, MO, NC, NJ, NY, OH, OR, SC, IA, AL, UT, PR OUS: Canada, Spain, France, Italy, India, Vietnam, Philippines |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051072 | BIO-RAD VARIANT NBS SICKLE CELL PROGRAM Bio-Rad Laboratories, Inc., May 12, 2005 |