Recall Z-1796-2018 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Siemens Healthcare Diagnostics, Inc.
Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
| Date | Dec 14, 2017 |
| Status | Terminated |
| Reason | Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits. |
| Root cause | Under Investigation by firm |
| Action | Customers are instructed to: - Discontinue use of Dimension LIPL Assay lot FB8109. - Recalibrate with an alternate lot of Dimension LIPL Assay. - Review their inventory of this lot to determine their laboratoryfs no-charge replacement needs. - Review the UMDR/UFSN letter with their Medical Director. - Complete and return the Field Correction Effectiveness Check Form attached to the UMDR/UFSN letter within 30 days. - If they have received any complaints of illness or adverse events associated with lot FB8109, immediately contact their local Siemens Customer Care Center or their local Siemens T |
| Distribution | Domestic and Foreign consignees |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.