Siemens recalls IMMULITE 2000 allergen test devices with specific barcode issues that may cause incorrect tube scanning when used with Zebra scanners. Affected units have SMN 10386105 or catalog L2KUN6. No action needed per recall.
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
Siemens is recalling IMMULITE 2000 allergen test devices that may scan tubes incorrectly when used with Zebra barcode scanners. This could lead to inaccurate allergy test results but does not cause physical harm. The recall does not require immediate action.
The barcode orientation on affected devices causes the device to misread tube positions in the allergen holder wedge when scanning with Zebra barcode scanners. This results in incorrect scanning order of test tubes, potentially causing inaccurate allergy test results. The issue does not involve physical harm or equipment damage.
Lab technicians and allergy testing facilities using the IMMULITE 2000 device with Zebra barcode scanners. Those with the specific Siemens Material Number 10386105 or catalog number L2KUN6 are most at risk.
Check for Siemens Material Number (SMN) 10386105 or catalog number L2KUN6 on the device. Affected units also have model T77L2 and lot number 627.
Verify the Siemens Material Number (SMN) 10386105 or catalog number L2KUN6 on the IMMULITE 2000 device.
No action is required per the recall. The issue only affects test accuracy, not safety.
The device may scan tubes incorrectly, leading to inaccurate allergy test results.
Check for Siemens Material Number (SMN) 10386105 or catalog number L2KUN6 on the device.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0491-2026 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0491-2026 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.
