Siemens Recalls Dimension Lipase Flex Reagent Cartridge Lot FB8109
Siemens Healthcare Diagnostics is recalling one lot of Dimension Lipase Flex Reagent Cartridges due to calibration failure causing positive bias in test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a calibration failure that produces inaccurate test results (positive bias), posing a risk of harm where injury has not yet been reported. This aligns with the High severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is voluntarily recalling a single lot of the Dimension Lipase Flex Reagent Cartridge (Catalog DF56, Lot FB8109). The recall affects units distributed to domestic and foreign consignees.
The company identified that lot FB8109 does not meet internal specifications for lot-to-lot limits. This calibration failure results in a confirmed positive bias when compared to other Dimension LIPL lots.
No further details regarding specific user actions or illness reports are provided in the source text.
The recalled product
- Product
- Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog DF56 Lot FB8109- UDI# (01)00842768025532(10)FB8109(17)20180419
Distribution
Distribution scope not specified by the agency.
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