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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