Diagnostic Hybrids Recalls MicroVue SC5b-9 Plus EIA Kits Due to Bacterial Contamination
Diagnostic Hybrids, Inc. is recalling 107 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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is bacterial contamination in a research-use-only product, fitting the criteria for a moderate severity score.
Plain-English summary
Diagnostic Hybrids, Inc. is recalling 107 units of the MicroVue SC5b-9 Plus EIA (RUO), Model A020. This is a research use only (RUO) enzyme immunoassay used for the quantitation of the SC5b-9 complex in human plasma or serum.
The recall was initiated because a component of the kit was found to contain bacterial contamination. The affected product is identified by Lot 052418.
The product was distributed worldwide, including nationwide in the United States to the states of CO, CT, IA, IL, MN, MO, NC, NY, OH, TX, and UT, as well as to Switzerland, India, Hong Kong, and Japan. Users should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
- Manufacturer
- Diagnostic Hybrids, Inc.
- Hazard
- Affected units
- 107
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 052418
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
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FDA (Devices) · 2018-05-02
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