Siemens Healthcare Diagnostics, Inc. recalls Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determin…

Recall date

March 25, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1703-2015

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Worldwide Distribution. US naionwide including Puerto Rico, Barbados and Mexico.

Why it was recalled

Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. Patient samples with recoveries close to the medical decision points could exhibit a deviation up to 4 seconds for the normal range and up to 33% for the pathological range.

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

What was recalled

Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.