Siemens Healthcare recalls specific IMMULITE 2000/2000 XPi TG models due to potential biotin interference in certain blood tests. Affected units may give inaccurate results if biotin levels are 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 2000/2000 XPi TG blood analyzers because they can give inaccurate test results when biotin is present in the patient's blood. This could lead to incorrect diagnoses if the device is used without proper biotin management.
The device may produce inaccurate test results for certain blood markers when biotin is present in the patient's blood. Biotin is a common vitamin found in some foods and supplements, so interference can happen if the patient takes biotin-containing products.
Lab users who operate the IMMULITE 2000/2000 XPi TG analyzers are affected. Those testing for specific biomarkers like CEA, Thyroglobulin, or Vitamin B12 may be at risk if biotin interference occurs.
Check for lot numbers 346-356 and D348-D356 on the IMMULITE 2000/2000 XPi TG devices. These models were sold with specific lot codes that are affected by biotin interference.
Look for lot numbers 346 through 356 or D348 through D356 on the IMMULITE 2000/2000 XPi TG device.
The IMMULITE 2000/2000 XPi TG devices may give inaccurate test results for certain blood markers when biotin is present in the patient's blood.
Tests for CEA, Thyroglobulin, Vitamin B12, and other specific biomarkers listed in the recall notice.
No, the recall does not require stopping use. Lab users should check for biotin interference and follow proper procedures to avoid inaccurate results.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1685-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1685-2018 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.
