Medical device recalls Moderate risk

Remel Inc recalls Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-la…

Recall date
March 24, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1921-2016
FDA classification
Class II
Brand / firm
Remel Inc
Sold / distributed
US distribution in MO.

Why it was recalled

Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.

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

What was recalled

Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic

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