Siemens Recalls Dimension Vista MMB Reagent Cartridges Due to Biotin Interference
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridges because the instructions for use do not list the biotin concentration that causes interference.
What this means for you
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 is FDA Class II, which typically corresponds to a High severity score when the hazard involves potential test interference that could lead to misdiagnosis or inappropriate treatment, even though no illnesses or injuries have been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. has issued a recall for the Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridge. The company identified that the instruction for use for this product does not currently list the concentration of biotin that does not interfere with test results.
The source text indicates that these assays are susceptible to interference from biotin. This issue also affects other Siemens and ADVIA assays, including Dimension CTNI, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM, and several IMMULITE assays such as 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12.
The recalled product is distributed nationwide in the United States as well as in Canada, Mexico, and Thailand. The specific lot codes affected are 16284BD, 16312BB, 17011BD, 17058BD, 17093BC, 17136BE, 17186BE, 17235BC, and 17268BA. The recall applies to the MMB reagent cartridge using the colorimetric method for cpk or isozymes (K6420, SMN# 10445097).
The recalled product
- Product
- Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
- 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 (4)
- MMB
- colorimetric method
- cpk or isozymes
- K6420
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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