—#137183

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.

FDA product code: GFO — Activated Partial Thromboplastin
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K760318
Affected lot / code info: 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

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

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

Timeline

Recall initiated: 2015-03-25
Posted by FDA: 2015-06-02
Terminated: 2017-01-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137183. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.