Dimension Lipase Flex¿ Reagent Cartridge recall
Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Why was Dimension Lipase Flex¿ Reagent Cartridge 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog DF56 Lot FB8109- UDI# (01)00842768025532(10)FB8109(17)20180419
- Product
- Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- N/A
- Distribution
- Domestic and Foreign consignees
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)