Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In vitro diagnostic test intended for the qua
FDA device recall Z-1930-2009 · posted 2009-09-08 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- falsely elevated results in EDTA plasma samples
- Action taken
- 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an Urgent Field Safety Notice on April 15, 2008 informing their customers that the EDTA plasma specimen claim had been rescinded.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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- DCN
- Quantity affected
- 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, G
- Date initiated
- 2008-04-15
- Date posted
- 2009-09-08
- Date terminated
- 2009-09-09
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RCRP FLEX REAGENT CARTRIDGE (K003419) | Dade Behring, Inc. | 2001-02-14 |