Z-1796-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- December 14, 2017
- Termination Date
- December 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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 Pattern
Domestic and Foreign consignees
Code Information
Catalog DF56 Lot FB8109- UDI# (01)00842768025532(10)FB8109(17)20180419