Diagnostic Hybrids Recalls MicroVue Bb Plus EIA Kits Due to Inaccurate Results
Diagnostic Hybrids Inc is recalling 171 MicroVue Bb Plus EIA kits because they produce concentration values approximately 50% higher than expected.
What this means for you
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 inaccurate diagnostic results without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Diagnostic Hybrids Inc is recalling 171 units of the MicroVue Bb Plus EIA kit, an in vitro diagnostic product. The recall is limited to Model Number A027, Lot Number 018186. The product was distributed in the United States (including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA) and in Canada, China, India, and Switzerland.
The recall was initiated because samples are quantitating incorrectly. The affected kits produce concentration values that are approximately 50% higher than previously reported and historically documented values. This inaccuracy may affect the reliability of test results for Complement Component Bb.
Users of the affected product should stop using the kits and contact Diagnostic Hybrids Inc for further instructions or a replacement.
The recalled product
- Product
- MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
- Manufacturer
- Diagnostic Hybrids Inc
- Hazard
- Affected units
- 171
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 (5)
- Model Number A027
- Lot Number 018186
- (self-affixed
- EDMA Code: 12 01 02 04 00
- Complement Component Bb)
Distribution
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