Dimension Lipase Flex Reagent Cartridge -… recallZ-1796-2018 · Siemens Healthcare Diagnostics, Inc. · initiated Dec 14, 2017
Class II Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-1796-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 14, 2017
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product code
- CHI
- Distribution
- Domestic and Foreign consignees
Product description
Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Code information (models, lots, serial numbers)
Catalog DF56 Lot FB8109- UDI# (01)00842768025532(10)FB8109(17)20180419
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Dimension® Flex® reagent cartridge LIPL 10460277Siemens Healthcare Diagnostics Inc. · LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE1 recall6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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