Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase Recalled by Siemens Healthcare Diagnostics, Inc. Due to Calibration failure - confirmed a positive bias with...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.
Affected Products
Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Quantity: N/A
Why Was This 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.
Where Was This Sold?
Domestic and Foreign consignees
About Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report