Recalls / —
—#91152
Product
Dimension LIP Flex Reagent Cartridge, Catalog# DF55A
- FDA product code
- CHI — Lipase-Esterase, Enzymatic, Photometric, Lipase
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K952816
- Affected lot / code info
- Lot Number: DE0320, FC0306, GB0342, EA0334, FB0278, DA0293, GB0286, FA0355, EA0362, EB0362.
Why it was recalled
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.
Root cause (FDA determination)
Other
Action the firm took
Recalling firm issued "Urgent Field Safety Notice", dated March 2010, informing users of the problem and to transition to the revised Lipasae method.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101
Distribution
- Distribution pattern
- Nationwide Distribution throughout the US.
Timeline
- Recall initiated
- 2010-03-10
- Posted by FDA
- 2010-12-10
- Terminated
- 2011-08-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #91152. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.