Z-1796-2018Class II

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

Name: Z-1796-2018 Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2017-12-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-12-14 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase) on 2017-12-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1796-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-14
Posted: 2018-05-10
Terminated: 2020-12-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
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.
Root cause tag: manufacturing process
FDA 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 Technical Support Representative
Distribution: Domestic and Foreign consignees
Product codes and lots: Catalog DF56 Lot FB8109- UDI# (01)00842768025532(10)FB8109(17)20180419

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1796-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1796-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10

Product code CHI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)