Diagnostic Hybrids Recalls MicroVue SC5b-9 Plus EIA Kits Due to Bacterial Contamination
Diagnostic Hybrids, Inc. is recalling 72 MicroVue SC5b-9 Plus EIA kits because a component was found to contain bacterial contamination.
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 FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is bacterial contamination, but the agency's classification suggests a low risk of harm, fitting the Moderate category for low-risk contamination or precautionary measures.
Plain-English summary
Diagnostic Hybrids, Inc. is recalling 72 units of the MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. This product is an enzyme immunoassay used for the quantitation of the SC5b-9 complex in human plasma or serum. The recall is limited to Lot 052419.
The recall was initiated because a component of the kit was found to contain bacterial contamination. The affected kits were distributed nationwide in the United States to the states of Colorado, Connecticut, Iowa, Illinois, Minnesota, Missouri, North Carolina, New York, Ohio, Texas, and Utah. The products were also distributed to Switzerland, India, Hong Kong, and Japan.
The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Users should stop using the affected kits and contact Diagnostic Hybrids, Inc. for further instructions.
The recalled product
- Product
- MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
- Manufacturer
- Diagnostic Hybrids, Inc.
- Hazard
- Affected units
- 72
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 (1)
- Lot 052419
Distribution
Part of a larger recall action
This product is one of 3 recalled by Diagnostic Hybrids, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Diagnostic Hybrids, Inc.
See all →- ModerateDiagnostic Hybrids Recalls MicroVue BAP EIA Kits Due to Leaking Bottles
FDA (Devices) · 2018-05-16
- ModerateDiagnostic Hybrids Recalls MicroVue CIC-C1q EIA Kits Due to Bacterial Contamination
FDA (Devices) · 2018-05-02
- LowQuidel MicroVue Intact PTH EIA Recalled for Potential Calibration Issues
FDA (Devices) · 2018-05-02
- ModerateDiagnostic Hybrids Recalls MicroVue CIC-C1q EIA Kits Due to Validation Concerns
FDA (Devices) · 2018-05-02
- ModerateDiagnostic Hybrids Recalls MicroVue SC5b-9 Plus EIA Kits Due to Bacterial Contamination
FDA (Devices) · 2018-05-02
Same hazard · bacterial contamination
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighCurry chicken salad flagged for possible Listeria contamination in two states
USDA FSIS · 2026-07-30
- ModerateMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- SevereSurgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads
FDA (Devices) · 2026-07-08