FDA-Device2018-05-16Class II
Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Siemens Healthcare Diagnostics, Inc.
Hazard
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.
Sold states
Domestic and Foreign consignees
Affected count
N/A
Manufactured in
500 Gbc Dr Ms 514, Po Box 6101, Newark, DE, United States
Products
Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1796-2018Don't want to check this manually?
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