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.
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📍Recalling firmSiemens Healthcare Diagnostics, Inc.333 Coney St · East Walpole, MA 02032-1516
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/51101-siemens-food-panel-3-allergen-barcode-scanning-issue-with-immulite.
“Siemens Food Panel 3 Allergen: Barcode Scanning Issue With IMMULITE 2000.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51101-siemens-food-panel-3-allergen-barcode-scanning-issue-with-immulite. Based on FDA recall #Z-0493-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0493-2026%22&limit=1).
The FDA announced on Oct. 6, 2025, that Siemens Healthcare Diagnostics, Inc. is recalling the Food Panel 3 Specific Allergen due to barcode orientation issues causing incorrect scanning order. The agency issued recall number Z-0493-2026 for the device.
How to tell if you have it
Brand: Siemens Healthcare
Product: Food Panel 3 Specific Allergen
Siemens Material Number (SMN): 10385891
Catalog Number: FP3L4
Lot number: 629
UDI-DI: 00630414960418
The hazard
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 with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls on record since June 7, 2017. Other recent recalls include the Atellica CH Revised C-Reactive Protein recall (Aug. 17, 2026) and the Atellica CH Urine Albumin Recall (July 6, 2026). Similar recent recalls of similar products include the Siemens Healthineers Immulite 2000 Syphilis Screen Recall (July 13, 2026).
How to tell if you have this one
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.
Brand
Siemens Healthcare
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution in the state of CA and the countries of Argentina, Australia, Austria, Belgium, Bosnia Herzeg. , Brazil, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Israel, Italy, Latvia, Macedonia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Portugal, Romania, Russian Fed., Serbia, Slovakia, Spain, Sweden, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay.
Recall number
Product, codes & lots
Quantity
Z-0491-2026
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;; Siemens Material Number (SMN): 10386105; Model/Catalog: T77L2; UDI-DI: 00630414965970; Lot number: 627;
34 units (1 US, 33 OUS)
Z-0492-2026
3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6;; Siemens Material Number (SMN): 10380875; Model/Catalog: L2KUN6; UDI-DI: 00630414962269; Lot number: 169, 170, 171, 172;
2802 units (OUS only)
Z-0493-2026
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;; Siemens Material Number (SMN): 10385891; Model/Catalog: FP3L4; UDI-DI: 00630414960418; Lot number: 629;
28 units (OUS only)
Based on the official FDA remedy
What to do — step by step
Check Device Details
Verify the Siemens Material Number (SMN) 10385891 or Catalog Number FP3L4 on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the state of CA and the countries of Argentina, Australia, Austria, Belgium, Bosnia Herzeg. , Brazil, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, France, Germany,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
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.
Official source: FDA Recall #Z-0493-2026 (October 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0493-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.