—#137172

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.

FDA product code: GJT — Plasma, Coagulation Factor Deficient
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K924396
Affected lot / code info: 10454742 10454729 10461894 10470625

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

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 -- 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, Montenegro, Qatar, Russia, San Marino, Saudi Arabia, Serbia, South Africa, United Arab Emirates, Argentina, Brazil, Chile, El Salvador, Peru, China, Mexico, Canada and United States.

Timeline

Recall initiated: 2015-05-11
Posted by FDA: 2015-06-05
Terminated: 2017-09-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137172. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.