FDA recall Z-1796-2018

Product

Dimension Lipase Flex¿ Reagent Cartridge - ( 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.

Distribution

Domestic and Foreign consignees

Key facts

Status

Terminated

Initiation date

2017-12-14

Report date

2018-05-16

Termination date

2020-12-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Newark, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1796-2018