Siemens Healthcare recalls IMMULITE 2000 Folic Acid devices due to potential biotin interference in certain tests. Affected units have specific lot numbers; users should check their device and follow official instructions.
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 IMMULITE 2000/2000 XPi Folic Acid devices because they may interfere with certain lab tests when biotin is present. This could lead to inaccurate test results if users take biotin supplements or consume biotin-rich foods.
The devices may produce inaccurate test results if biotin is present in the sample. Biotin is found in some supplements and foods, and the current instructions don't list the correct biotin concentration levels for these tests.
Users of IMMULITE 2000/2000 XPi Folic Acid devices with lot numbers 502-506, 508, or 514 are affected. People who take biotin supplements or consume biotin-rich foods are at higher risk of inaccurate test results.
Check the lot number on your IMMULITE 2000/2000 XPi Folic Acid device. Affected units have lot numbers 502, 503, 504, 505, 506, 508, or 514.
Identify the lot number on your IMMULITE 2000/2000 XPi Folic Acid device to see if it is affected.
The devices may produce inaccurate test results if biotin is present in the sample, as the current instructions don't list the correct biotin concentration levels for these tests.
Check the lot number on your device; if it is 502, 503, 504, 505, 506, 508, or 514, you may need to contact Siemens Healthcare for further instructions.
No, the recall does not require stopping use immediately. However, users should check the lot number and follow the manufacturer's instructions if affected.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1676-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1676-2018 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.
