FDA-Device2015-06-10Class II
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.
Siemens Healthcare Diagnostics, Inc.
Hazard
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.
Sold states
Worldwide Distribution. US naionwide including Puerto Rico, Barbados and Mexico.
Affected count
27501
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1703-2015Don't want to check this manually?
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