Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitativ
FDA device recall Z-2177-2011 · posted 2011-05-10 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Patient results may be falsely depressed or falsely elevated across the assay range.
- Action taken
- Siemens issued an Urgent Field Safety Notice dated June 2010 to all Dimension(R) EZCR customers; to notify them that Siemens confirmed an issue which many cause EZCR results to be falsely depressed or falsely elevated across the assay range. The letter asks users to discontinue use of this lab test kit.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JFY
- Quantity affected
- 860
- Distribution
- Nationwide distribution.
- Date initiated
- 2010-06-10
- Date posted
- 2011-05-10
- Date terminated
- 2013-03-19
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (K073055) | Dade Behring, Inc. | 2008-01-03 |