—#81857

Product

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.

FDA product code: DCN — System, Test, C-Reactive Protein
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K003419
Affected lot / code info: Catalog Number DF34; Lot Numbers: CE8324 exp 11/19/2008, BA8349 exp 12/14/2008, FB9003 exp1/3/2009, BC9017 exp1/17/2009, EC9021 exp1/21/2009, DB9032 exp2/1/2009, and DC9045 exp2/14/2009.

Why it was recalled

falsely elevated results in EDTA plasma samples

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

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an Urgent Field Safety Notice on April 15, 2008 informing their customers that the EDTA plasma specimen claim had been rescinded.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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: 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, Switzerland, Turkey, Yemen, Bahamas, Brazil, Canada, Mexico, Australia, Bangladesh, China, Hong Kong, Japan, Malaysia, Pakistan, and Taiwan.

Timeline

Recall initiated: 2008-04-15
Posted by FDA: 2009-09-08
Terminated: 2009-09-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81857. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.