Reported Jun 7, 2017 · Terminated

Elecsys PreciControl Varia 3

Roche Diagnostics 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: Roche Diagnostics Corporation · 9115 Hague Rd · Indianapolis, IN · 46256-1025

Is this the product you have?

  • Elecsys PreciControl Varia 3
Lot codes and dates
  • Lot Number189285
  • Expiration Date10/31/2017
  • Part NumberPreciControl
  • Varia05618860160
Amount recalled
1603

Where it was sold

  • Nationwide

Why it was recalled

e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays

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 Aug 4, 2017 · Data as of Sep 19, 5:21 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.