FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
- Recall number
- Z-1796-2018
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
- Status
- Terminated
- Initiated
- 2017-12-14
- Posted
- not on file
- Terminated
- 2020-12-03
- 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 Technical Support Representative
- Quantity
- not on file
- Distribution
- Domestic and Foreign consignees
- Lot, serial or model codes
- Catalog DF56 Lot FB8109- UDI# (01)00842768025532(10)FB8109(17)20180419
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CHI
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28