—#162393

Product

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

FDA product code: CHI — Lipase-Esterase, Enzymatic, Photometric, Lipase
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Catalog DF56 Lot FB8109- UDI# (01)00842768025532(10)FB8109(17)20180419

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr Po Box 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Domestic and Foreign consignees

Timeline

Recall initiated: 2017-12-14
Terminated: 2020-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162393. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.