Class 2 Device Recall VARIANT nbs Sickle Cell Program Reorder Pack 2503000

• Date Initiated by Firm: April 07, 2022
• Create Date: May 28, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1208-2022
• Recall Event ID: 90027
• 510(K)Number: K051072
• Product Classification: Abnormal hemoglobin quantitation - Product Code GKA
• Product: Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
• Code Information: REF: 250-3020/Lot: AX90085, AY90085, AZ90085, BB90085, CB90085, DB90085; REF: 250-3000, UDI/DI: 00847817008276, Lot/Expiry: 64442741/ 2/28/2023, 64444208/ 2/28/2023, 64444218/ 3/26/2023, 64444715/ 3/31/2023, 64452929/ 3/31/2023, 64452922/ 5/31/2023
• Recalling Firm/ Manufacturer: Bio-Rad Laboratories, Inc.; 4000 Alfred Nobel Dr; Hercules CA 94547-1803
• For Additional Information Contact: 510-741-4579
• Manufacturer Reason for Recall: 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. However, there is a risk that the customer's custom pattern settings may be different than the default settings, resulting in a different pattern being assigned to some samples that the laboratory has validated. Following the complaints from 4 customers who experienced these issues, the firm initiated this recall.
• FDA Determined 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 settings. If affected: 1. Go to the Setup/Test/Data Setup and/or Setup/Test/Pattern Setting subscreen. Click the Allow Editing button and enter the password. 2. Enter your preferred settings in each of the applicable subscreens. 3. Click the Lock Editing button. 4. Do not perform the Update Kit procedure again with any of the affected Resin Update CD-ROMs. 5. Review all sample reports specifically for your customized setting(s) that reverted to the default setting(s). Refer to Operation Manual (LB001682revB) Section 6.1.7 Additionally, If your lab customized selections in the Data Setup tabs (Sample Types, Peak Result Export, and/or Sample Result Export), then reset them. The default settings have all pertinent patient information selected; any unselected parameters do not affect the patient results. LIS not affected; refer to Software Operation Manual Section 6.1.6. If assistance is needed with recovering overwritten customized settings, an old database can be temporarily restored and then the customized Data Setup settings and/or Pattern settings can be copied/printed. Restore the working database before proceeding to prevent loss of data. Complete and return the response form. The following contact was provided by the firm: 510-724-7000
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GKA