Device product

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

Z-1796-2018

December 14, 2017

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc.
Event: Event 79468
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: device-enforcement:Z-1796-2018

Official wording

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.

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

Distribution pattern: Domestic and Foreign consignees

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.