Quidel Recalls Sofia 2 Analyzers Due to Calibration Error
Quidel is recalling 482 Sofia 2 Analyzers because a manufacturing error may cause calibration failure or incorrect test results.
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, and the source describes the risk of incorrect results as a 'remote possibility' without reporting any actual injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Quidel Corporation is recalling 482 units of the Sofia 2 Analyzer (Catalog Number 20299) in the United States. The Sofia 2 is a benchtop analyzer intended for professional and laboratory use with cassette-based immunofluorescent in vitro diagnostic assays.
The recall was initiated because the calibration for the affected batch of analyzers was incorrectly set during the manufacturing process. This error may lead to a failure when calibration is first performed. Additionally, there is a remote possibility that incorrect qualitative test results for patient samples near the assay cutoff may be reported.
The affected units are identified by specific serial numbers listed in the official recall notice. Users should check their equipment against the provided list of serial numbers. If a unit is affected, it should be removed from service and returned to Quidel Corporation for repair or replacement.
The recalled product
- Product
- Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
- Manufacturer
- Quidel Corporation
- Affected units
- 482
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 (20)
- Serial Numbers: 29003956
- 29004025
- 29004086
- 29004072
- 29004188
- 29004150
- 29004229
- 29004127
- 29004232
- 29004204
- 29004256
- 29004362
- 29004155
- 29004290
- 29004329
- 29004347
- 29004350
- 29004353
- 29004370
- 29004390
Distribution
Distribution scope not specified by the agency.
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