Recall Z-0588-2011 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Siemens Healthcare Diagnostics, Inc.
Dimension LIP Flex Reagent Cartridge, Catalog# DF55A
| Date | Dec 10, 2010 (initiated Mar 10, 2010) |
| Status | Terminated |
| Reason | 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 | Other |
| Action | Recalling firm issued "Urgent Field Safety Notice", dated March 2010, informing users of the problem and to transition to the revised Lipasae method. |
| Quantity | 21171 |
| Distribution | Nationwide Distribution throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952816 | LIPASE FLEX REAGENT CARTRIDGE Dupont Medical Products, Jul 20, 1995 |