Diagnostic Hybrids Inc MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic. Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Brand
Diagnostic Hybrids Inc
Lot Codes / Batch Numbers
Model Number A027, Lot Number 018186, (self-affixed, EDMA Code: 12 01 02 04 00, Complement Component Bb)
Products Sold
Model Number A027; Lot Number 018186; (self-affixed, EDMA Code: 12 01 02 04 00; Complement Component Bb)
Diagnostic Hybrids Inc is recalling MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. due to Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CO, CT, FL, KY, MN, NV, NC, OH, PA, WA
Page updated: Jan 10, 2026