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Terminated

Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)

FDA Recall Z-1796-2018 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeCHI
Date Initiated2017-12-14
Date Terminated2020-12-03

Reason for Recall

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.

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 Technical Support Representative

Root Cause

Under Investigation by firm

Distribution Pattern

Domestic and Foreign consignees

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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