Reported Jun 17, 2020 · Terminated

4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number:…

Biocare Medical, LLC

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: Biocare Medical, LLC · 60 Berry Dr · Pacheco, CA · 94553-5601

Is this the product you have?

  • 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component
  • Catalog NumberHP604H
Lot codes and dates
  • Lot Number041619-4
  • Expiration Date2020/10
Amount recalled
8

Where it was sold

Why it was recalled

Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis.

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 Dec 2, 2020 · Data as of Sep 19, 5:26 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.