Bio-Rad Sickle Cell Testing Software CD-ROM Defect Overwrites Custom Settings

Plain-English summary

Bio-Rad Laboratories, Inc. is recalling the Resin UPDATE CD-ROM (Model 250-3020), which is included in the VARIANT nbs Sickle Cell Program Reorder Pack (Model 250-3000). The software defect causes the Update Kit procedure to overwrite all customized settings in the Setup/Test/Data Setup and Setup/Test/Pattern Setting subscreens with default settings.

The VARIANT nbs Sickle Cell Program has been validated using default settings. Laboratories may have customized these settings to meet their specific needs. When the update is performed, these custom settings are lost and replaced with defaults, creating a risk that samples may be assigned different patterns than those the laboratory has previously validated. Bio-Rad initiated this recall following reports from four customers who encountered this issue.

The recall affects 1,893 units distributed throughout the United States (Arizona, Arkansas, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, South Carolina, Tennessee, Utah, Virginia, Iowa, Alabama, and Puerto Rico), as well as Canada, Spain, France, Italy, India, Vietnam, and the Philippines. Affected lots include AX90085, AY90085, AZ90085, BB90085, CB90085, and DB90085 for Model 250-3020.

Laboratories using or planning to use the affected software should contact Bio-Rad Laboratories for corrective action and information regarding the defect and available solutions.

The recalled product

Product

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

Manufacturer

Bio-Rad Laboratories, Inc.

Category

Medical Device — Diagnostic Testing Equipment

Hazard

• software-defect
• mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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