Bio-Rad Recalls EVOLIS Microplate System Due to Software Error
Bio-Rad is recalling 213 EVOLIS Microplate Systems because a software defect may cause erroneous test results to be transmitted to laboratory information systems.
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 data integrity errors (erroneous results) rather than a direct physical injury or high-risk pathogen, and no illnesses or injuries are reported in the source text.
Plain-English summary
Bio-Rad Laboratories, Inc. is recalling 213 units of the EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software (Catalog no. 90471A). The recall involves software version 1.4, identified by UDI 03610520562024.
The recall is due to a software defect where user-induced circumstances can cause the system to improperly handle repeat testing requests or results. This issue may result in the transmission of erroneous data to the customer's Laboratory Information System (LIS).
The affected devices were distributed nationwide to medical facilities, including in Puerto Rico, as well as to government and military entities. There was no foreign distribution. The source text does not specify instructions for consumers or facilities regarding the next steps for this recall.
The recalled product
- Product
- EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
- Manufacturer
- Bio-Rad Laboratories, Inc
- Affected units
- 213
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 (2)
- Software version 1.4
- UDI for the software is 03610520562024.
Distribution
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