Medical device recalls Moderate risk

Roche Diagnostics Corporation recalls Elecsys PreciControl Varia 3

Recall date
April 10, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2173-2017
FDA classification
Class II
Brand / firm
Roche Diagnostics Corporation
Sold / distributed
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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Elecsys PreciControl Varia 3

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