Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1796-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 14, 2017

Date Posted: May 16, 2018

Recall Number: Z-1796-2018

Event ID: 79468

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.

Status: Terminated

Product Quantity: N/A

Code Information:

Catalog DF56 Lot FB8109- UDI# (01)00842768025532(10)FB8109(17)20180419

Distribution Pattern:

Domestic and Foreign consignees

Voluntary or Mandated:

Voluntary: Firm initiated