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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Diagnostic Hybrids, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 28, 2020 · Data as of Sep 19, 5:30 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.