Reported Jun 12, 2019 · Ongoing

Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019,…

Microbiologics Inc.

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: Microbiologics Inc · 200 Cooper Ave N · Saint Cloud, MN · 56303-4440

Is this the product you have?

  • Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196)
  • UDI70845357041233
  • Product Usage
    • On April 9
    • 2019
  • Microbiologics sent ACTION REQUIREDMEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand
Lot codes and dates
  • Cepheid Xpert¿ SA Nasal Complete Control
  • Panel Catalog Number 8196 Lot Numbers
    • 8196-04
    • 8196-05
    • 8196-06
    • 8196-07
    • 8196-08 8196-09
    • 8196-10
    • and 8196-14
Amount recalled
235

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Product with incorrect shelf life.

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

Data as of Sep 19, 7:33 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.