Diagnostic Hybrids Recalls MicroVue CIC-C1q EIA Kits Due to Bacterial Contamination
Diagnostic Hybrids, Inc. is recalling 19 MicroVue CIC-C1q 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 the rubric indicates is typically a score of 1 or 2. The hazard is bacterial contamination, but no specific illnesses or injuries are reported in the source text, placing it in the Moderate range for a low-risk contamination event.
Plain-English summary
Diagnostic Hybrids, Inc. is recalling 19 units of the MicroVue CIC-C1q EIA, Model A001, Lot 051076. The recall was initiated because a component of the kit was found to contain bacterial contamination.
The MicroVue CIC-C1q EIA is a medical device used for the detection of circulating immune complexes (CIC) in human serum or plasma. 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 kits were also distributed internationally to Switzerland, India, Hong Kong, and Japan.
Consumers and healthcare facilities should stop using the affected kits and contact Diagnostic Hybrids, Inc. for instructions on return or replacement.
The recalled product
- Product
- MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immu
- Manufacturer
- Diagnostic Hybrids, Inc.
- Hazard
- Affected units
- 19
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 051076
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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