Siemens Healthcare recalls allergy test kits with barcode scanning problems that may cause incorrect tube readings. Affected kits need replacement to ensure accurate allergy test results.
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 allergy test kits that may cause incorrect scanning of test tubes when used with certain instruments. This could lead to inaccurate allergy test results if the barcode orientation is not properly aligned.
The barcode orientation on the affected kits causes the instrument to misread the tube order in the allergen holder wedge. This can lead to incorrect test results when used with specific instruments and scanners.
Allergy test users who purchased the affected kits from Siemens Healthcare. Those using the kits with IMMULITE 2000 or IMMULITE 2000 XPi instruments and Zebra barcode scanners are most at risk.
Check for the Siemens Material Number (SMN) 10380875 or Catalog Number L2KUN6 on the kit. Affected kits were sold with lot numbers 169, 170, 171, or 172.
Verify the Siemens Material Number (SMN) 10380875 or Catalog Number L2KUN6 on the kit.
Contact Siemens Healthcare to get a replacement kit if you have the affected model.
The barcode orientation on affected kits causes incorrect scanning of test tubes when used with specific instruments and scanners.
Check the kit for the Siemens Material Number (SMN) 10380875 or Catalog Number L2KUN6. Contact Siemens Healthcare for a replacement if you have the affected model.
No injury risk is mentioned in the recall. The hazard is limited to potential inaccurate test 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-0492-2026 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0492-2026 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.
