Z-1703-2015Class II

Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in...

Name: Z-1703-2015 Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-03-25
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-03-25 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial... on 2015-03-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1703-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-25
Posted: 2015-06-02
Terminated: 2017-01-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: GFO Activated Partial Thromboplastin
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: On March 24, 2015 an Urgent Medical Device Recall letter was mailed to all affected customers to notify them about the issue, associated risks, and actions to be taken.
Quantity in commerce: 27501
Distribution: Worldwide Distribution. US naionwide including Puerto Rico, Barbados and Mexico.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1703-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1703-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-10	2015-06-02

Product code GFO

K760318Class IIActin, Activated Cephaloplastin ReagentDade, Baxter Travenol Diagnostics, Inc. / cleared 1976-08-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)