Siemens IMMULITE Gastrin Assay Recalled for Biotin Interference
Siemens Healthcare Diagnostics is recalling IMMULITE Gastrin assays because biotin interference is not listed in the instructions for use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a labeling omission regarding biotin interference, which is a moderate risk of inaccurate test results rather than a direct physical injury or high-risk pathogen.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE /IMMULITE 1000 Gastrin assay. The recall is due to the fact that the concentration of biotin that does not interfere with the test is not currently listed in the instruction for use.
The source text indicates that the IMMULITE Gastrin assay is susceptible to interference from biotin. This issue affects the specific lot codes 0345, 0346, and 0347 for the Gastrin assay. The product was distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand.
Consumers and healthcare providers should stop using the affected IMMULITE Gastrin assays and contact Siemens Healthcare Diagnostics for further instructions or replacement.
The recalled product
- Product
- IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
- 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 (5)
- Gastrin
- Gastrin (IMMULITE/IMMULITE 1000
- LKGA1)
- (IMMULITE 2000/IMMULITE 2000 XPi
- LKGA2) Lot codes: Gastrin Lot # 0345 0346 0347
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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