Dade Actin Activated Cephaloplastin Reagent recallZ-1703-2015 · Siemens Healthcare Diagnostics, Inc. · initiated Mar 25, 2015
Class II Terminated All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1703-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 25, 2015
- Posted by the FDA
- Jun 2, 2015
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 27501
- Product code
- GFO
- FDA submissions
- K760318
- Distribution
- Worldwide Distribution. US naionwide including Puerto Rico, Barbados and Mexico.
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under K760318 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dade® Actin® Activated Cephaloplastin Reagent 10445711Siemens Healthcare Diagnostics Products GmbH · ACTIVATED PARTIAL THROMBOPLASTIN12 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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