Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vitro diagnostic test for the qua
FDA device recall Z-0485-2009 · posted 2008-12-13 · Terminated
Recall details
- Recalling firm
- Dade Behring, Inc.
- Reason for recall
- Reagent may exhibit unflagged inaccurate patient sample results.
- Action taken
- The recalling firm telephoned all customers on 9/29/08 to inform them of the problem. Customers were issued a letter dated 9/29/08 (and a response form) with instructions. Customers were instructed to complete the response form and fax (302-631-7242) it to Siemens Healthcare Diagnostics. For questions or additional information, contact the Siemens Technical Solutions Center at 800-441-9250.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JFY
- Quantity affected
- 12,773 cartons
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-09-29
- Date posted
- 2008-12-13
- Date terminated
- 2009-03-27
- Location
- Newark, DE
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (K073055) | Dade Behring, Inc. | 2008-01-03 |