Siemens Healthcare recalls Food Panel 3 Specific Allergen (SMN 10385891) due to barcode scanning errors with IMMULITE 2000 instruments. Affected units may not correctly read tube positions in allergen holders when used with Zebra scanners.
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 Healthcare is recalling Food Panel 3 Specific Allergen devices because their barcode orientation causes the IMMULITE 2000/2000 XPi instruments to misread tube positions when paired with Zebra barcode scanners. This could lead to incorrect allergy test results if the scanner fails to properly identify tube sequences.
The barcode orientation on the Food Panel 3 device causes the IMMULITE 2000/2000 XPi instruments to misread the order of test tubes in the allergen holder wedge when used with Zebra barcode scanners. This error can lead to incorrect allergy test results if the scanner fails to properly identify tube sequences.
Users of the Food Panel 3 Specific Allergen test devices with IMMULITE 2000 or 2000 XPi instruments who also use Zebra barcode scanners are affected. Laboratory staff and healthcare providers who run these tests are most at risk of inaccurate results.
Check for Siemens Material Number (SMN) 10385891 or Catalog Number FP3L4 on the device. Affected units also have UDI-DI: 00630414960418 and Lot number 629.
Verify the Siemens Material Number (SMN) 10385891 or Catalog Number FP3L4 on the device.
The barcode orientation on affected Food Panel 3 devices causes the IMMULITE 2000/2000 XPi instruments to misread tube positions when used with Zebra barcode scanners, potentially leading to incorrect allergy test results.
The recall record does not specify a remedy or action steps beyond checking device details. Contact Siemens Healthcare for further guidance if you have the affected model.
The recall describes a potential for incorrect test results, not physical injury. There is no mention of safety hazards like fire or injury in normal use.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0493-2026 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0493-2026 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.
