Z-1208-2022Class II

Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000

Name: Z-1208-2022 Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Creator: Bio-Rad Laboratories, Inc.
Published: 2022-04-07
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2022-04-07 / Open, Classified / root cause: packaging

FDA source

Bio-Rad Laboratories, Inc. began a recall of Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000 on 2022-04-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1208-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-07
Posted: 2022-05-28
Recalling firm: Bio-Rad Laboratories Inc.
Product: Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Product code: GKA Abnormal Hemoglobin Quantitation
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.
Root cause tag: packaging
FDA 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 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1208-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1208-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-08	2022-05-28

Product code GKA

K051072Class IIBio-Rad Variant Nbs Sickle Cell ProgramBio-Rad Laboratories, Inc. / cleared 2005-05-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)