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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In vitro diagnostic test due to falsely elevated results in EDTA plasma samples. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
falsely elevated results in EDTA plasma samples
Recommended Action
Per FDA guidance
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an Urgent Field Safety Notice on April 15, 2008 informing their customers that the EDTA plasma specimen claim had been rescinded.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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026