Siemens Healthcare recalls IMMULITE 1000 Vitamin B12 devices with specific lot codes due to potential biotin interference in certain blood tests. Affected units may give inaccurate results if biotin is present in the patient's blood.
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
Siemens Healthcare is recalling specific models of IMMULITE 1000 Vitamin B12 blood analyzers because they can give inaccurate test results if biotin is present in the patient's blood. This could lead to incorrect diagnoses of certain conditions.
The recalled devices may produce inaccurate blood test results when biotin is present in the patient's blood. Biotin is a common vitamin found in some foods and supplements. The interference can cause false positive or negative results for specific blood tests.
People who use the IMMULITE 1000 Vitamin B12 blood analyzers with lot codes 0338-0341 are affected. Those who have recently had blood tests for conditions like cancer or thyroid issues may be at higher risk of inaccurate results.
Check the lot code on the device, which should be one of 0338, 0339, 0340, or 0341. The product is labeled as IMMULITE 1000 Vitamin B12.
Look for the lot code on the device, which should be 0338, 0339, 0340, or 0341.
The IMMULITE 1000 Vitamin B12 devices with specific lot codes can give inaccurate blood test results if biotin is present in the patient's blood, which may lead to incorrect diagnoses.
Check the lot code on the device. If it is 0338, 0339, 0340, or 0341, contact Siemens Healthcare for further instructions.
The recall is for potential inaccurate test results, not a direct risk of injury. The danger level is low risk.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1686-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1686-2018 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
