Siemens Healthcare recalls IMMULITE 1000 TG devices due to unlisted biotin concentrations causing false results in specific blood tests. Affected units have specific lot codes.
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 1000 TG blood analyzers because they may produce inaccurate test results due to unlisted biotin concentrations. This could lead to incorrect medical diagnoses if used without proper biotin management.
The devices may produce false test results when biotin levels exceed what's listed in the instructions. This happens because the current instructions don't specify the biotin concentration that could interfere with certain blood tests.
Users of IMMULITE 1000 TG blood analyzers with specific lot codes (0289, 0290, 0291, D0289, D0290, D0291) are affected. Laboratory staff and healthcare providers using these devices are most at risk.
Check the lot code on the device label. Affected units have lot codes 0289, 0290, 0291, D0289, D0290, or D0291.
Identify the lot code on the device label to determine if it's affected (0289, 0290, 0291, D0289, D0290, D0291).
The IMMULITE 1000 TG devices may produce inaccurate test results due to unlisted biotin concentrations that interfere with specific blood tests.
Check the lot code on your device label. If it's one of the affected codes (0289, 0290, 0291, D0289, D0290, D0291), contact Siemens Healthcare for further instructions.
The recall addresses potential false test results, not immediate safety risks like injury or fire. This is a low-risk issue related to test accuracy.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1684-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1684-2018 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.
