Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
FDA device recall Z-0069-2012 · posted 2011-10-19 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Firm has confirmed customer complaints for low recovery of QC and patient samples.
- Action taken
- Siemens Healthcare Diagnostics, Inc. Urgent Field Safety Notice was sent to customers on August 31, 2011 regarding the issue. The letter instructs customers to immediately discontinue use of the affected lots and discard all remaining inventory.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 6,072 cartons
- Distribution
- Worldwide distribution: USA, Puerto Rico, Guam, Austria, Canada, Croatia, France, Greece, Germany, Italy, Japan, Mexico, Portugal, Spain and Switzerland.
- Date initiated
- 2011-08-31
- Date posted
- 2011-10-19
- Date terminated
- 2014-01-14
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 (K081643) | Siemens Healthcare Diagnostics | 2008-07-03 |