Medical device recalls Moderate risk

Instrumentation Laboratory Co. recalls Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

Recall date
August 2, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0895-2018
FDA classification
Class II
Brand / firm
Instrumentation Laboratory Co.
Sold / distributed
Worldwide Distribution - US Nationwide

Why it was recalled

Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.

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

What was recalled

Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

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