Reported May 2, 2018 · Terminated
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation…
Diagnostic Hybrids, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diagnostic Hybrids, Inc. · 2005 E State St Ste 100 · Athens, OH · 45701-2125
Is this the product you have?
- 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.
- Lot codes and dates
- Lot 052418
- Amount recalled
- 107 kits
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
A component of the kit was found to contain bacterial contamination.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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