Dimension LIP Flex Reagent Cartridge, Catalog# DF55A
FDA device recall Z-0588-2011 · posted 2010-12-10 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration.
- Action taken
- Recalling firm issued "Urgent Field Safety Notice", dated March 2010, informing users of the problem and to transition to the revised Lipasae method.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHI
- Quantity affected
- 21171
- Distribution
- Nationwide Distribution throughout the US.
- Date initiated
- 2010-03-10
- Date posted
- 2010-12-10
- Date terminated
- 2011-08-04
- Location
- Newark, DE
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIPASE FLEX REAGENT CARTRIDGE (K952816) | Dupont Medical Products | 1995-07-20 |