Diagnostic Hybrids, Inc. recalls MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in…
- Recall date
- November 3, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1499-2018
- FDA classification
- Class III
- Brand / firm
- Diagnostic Hybrids, Inc.
- Sold / distributed
- Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.
Why it was recalled
A component of the kit was found to contain bacterial contamination.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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