Siemens Healthcare Diagnostics, Inc. recalls Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esteras
Recalled Product
Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Hazard / Issue
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.
Issued by
FDA
Distribution: Domestic and Foreign consignees
Lot/Code Info: Catalog DF56 Lot FB8109- UDI# (01)00842768025532(10)FB8109(17)20180419
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