Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent for the determination of the ac
FDA device recall Z-1713-2015 · posted 2015-06-05 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- GJT
- Quantity affected
- 3,575
- Distribution
- Worldwide Distribution -- Austria, Bulgaria, Belgium, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey,
- Date initiated
- 2015-05-11
- Date posted
- 2015-06-05
- Date terminated
- 2017-09-12
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA (K924396) | Behring Diagnostics, Inc. | 1993-05-21 |