Reported Oct 5, 2016 · Terminated

DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the…

Microgenics Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Microgenics Corporation · 46500 Kato Rd · Fremont, CA · 94538-7310

Is this the product you have?

  • DRI Salicylate Serum Tox Assay, Catalog number 0977
  • ToxicologyThe DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma
Lot codes and dates
    • Lot Number Expiration Date 60704602 DEC 2016
    • 72035410 JUL 2017
    • 72208738 FEB 2018
    • 72409454 OCT 2018
Amount recalled
1708 kits

Where it was sold

Why it was recalled

Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 21, 2016 · Data as of Sep 19, 6:01 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.