Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.
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 involves a medical device assay susceptible to biotin interference, which poses a risk of harm through inaccurate results. No illnesses or injuries have been reported, and the FDA classification is Class II, fitting the criteria for High severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is issuing a recall for certain lots of IMMULITE assays, including CEA, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12. The recall affects products distributed nationwide in the United States as well as in Canada, Mexico, and Thailand.
The reason for the recall is that the instructions for use for these assays do not currently list the concentration of biotin that does not interfere with test results. Consequently, these specific assays are susceptible to interference from biotin, which could lead to inaccurate diagnostic outcomes.
The recalled lot codes include 0355, 0356, and 0357 for CEA, and 311, 312, and 313 for the CEA Lot # containing 200 tests. The affected product line is identified as IMMULITE 2000/IMMULITE 2000 XPi CEA.
The source text does not specify what consumers or healthcare providers should do with the recalled products, nor does it report any current illnesses or injuries resulting from this issue.
The recalled product
- Product
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
- 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 (6)
- CEA
- CEA (IMMULITE/IMMULITE 1000
- LKCE1)
- (IMMULITE 2000/IMMULITE 2000 XPi
- LKCE2
- LKCE6) Lot codes: 0355 0356 0357 CEA Lot # 200 tests 311 312 313
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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