Siemens Healthcare Diagnostics, Inc. recalls Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)

Recall date

December 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1796-2018

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Domestic and Foreign consignees

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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