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Recall Observatory FDA recall evidence

Device product

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.

Z-1703-2015

March 25, 2015

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 71273
Status
Terminated
Classification
Class II
Quantity
27501
Official record key
device-enforcement:Z-1703-2015

Official wording

Reason: 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.

Code information: Catalog Number B4218-1, Material Number 10445709, lot numbers 557128, 557129, 557130, 557131, 557132, 557133, 557134, 557135, 557140, 557141 , expiration dates:10/31/2015, 11/21/2015, 2/16/2016

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.