Recall Z-1713-2015— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1713-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-11

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2015-05-11, terminated 2017-09-12. It names one FDA 510(k) clearance: K924396. Product: Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.. Reason: Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-05-11
Terminated: 2017-09-12
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K924396 — CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMABehring Diagnostics, Inc.·cleared 1993-05-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.

Reason for recall

Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range.

Data sourced from openFDA. This site is unofficial and independent of the FDA.