Recall Z-1930-2009 ยท DCN System, Test, C-Reactive Protein
Siemens Healthcare Diagnostics, Inc.
Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
| Date | Sep 8, 2009 (initiated Apr 15, 2008) |
| Status | Terminated |
| Reason | falsely elevated results in EDTA plasma samples |
| Root cause | Labeling False and Misleading |
| Action | Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice on April 15, 2008 informing their customers that the EDTA plasma specimen claim had been rescinded. Current lots in the firm's inventory have been put on hold and reworked with an Alert Card rescinding the EDTA plasma claim. Subsequent lots use a revised instruction for use stating "Do not use EDTA plasma" in the Specimen Collection and Handling Section. For further questions, contact Siemens Healthcare Diagnostics at 1-302-631-6564. |
| Quantity | 25,760 cartons |
| Distribution | Worldwide Distribution -- US, Austria, Bosnia, Czech Republic, Hungary, Slovakia, Serbia, Denmark, Estonia, Latvia, Lithuania, Norway, Sweden, Belgium, Cyprus, Canary Islands, France, Great Britain, Germany, Ireland, Italy, Netherlands, Poland, Russia, Portugal, Saudi Arabia, Spain, South Africa, Sw |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003419 | RCRP FLEX REAGENT CARTRIDGE Dade Behring, Inc., Feb 14, 2001 |