Bio-Rad Variant II beta-thalassemia Short Program kits recalled for buffer issues
Bio-Rad is recalling Variant II beta-thalassemia Short Program kits because buffer issues may cause calibration and quality control failures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential test failures and inaccurate quantification rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving low-risk contamination or functional defects.
Plain-English summary
Bio-Rad Laboratories, Inc. is recalling 457 kits of the Variant II beta-thalassemia Short Program, Model Numbers 270-2103 and 270-2154. The recall involves specific lots with catalog numbers 270-2103 (lot 64005302) and 270-2154 (lots 64005207 and 64004750).
The recall is due to an issue with the buffers that impacts the quantification of the Hemoglobin F peak. The source states that calibration and quality control are likely to fail if the affected lots are used.
The affected products were distributed worldwide, including in the United States and internationally to China, Australia, Canada, France, Great Britain, Hong Kong, Thailand, Singapore, and Brazil. Users should stop using the affected lots and contact Bio-Rad Laboratories for further instructions.
The recalled product
- Product
- Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the…
- Manufacturer
- Bio-Rad Laboratories, Inc.
- Affected units
- 457
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Catalog number: 270-2103 (250 tests
- Reorder pack lot number: 64005302
- Expiration: 4/2015
- Catalog number: 270-2154 (500 tests) Reorder pack lot number: 64005207
- Expiration: 6/2015
- 64004750
- Expiration: 11/2015
Distribution
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