Recall Z-1713-2015 ยท GJT Plasma, Coagulation Factor Deficient
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Jun 5, 2015 (initiated May 11, 2015) |
| Status | Terminated |
| Reason | Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Recall notice, dated May 2015, was sent to affected customers to inform them about the issue and associated risks. Customers were asked to discontinue use, distribute this information to all appropriate personnel, and to complete and fax back to Siemens the Effectiveness Check form. |
| Quantity | 3,575 |
| Distribution | Worldwide Distribution -- Austria, Bulgaria, Belgium, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey, Croatia, Bahrain, Belarus, Bosnia-Herzegovina, Guadeloupe, Kuwait, Lebanon, Libya, Macedonia, Monten |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924396 | CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA Behring Diagnostics, Inc., May 21, 1993 |