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IMMULITE®2000 Systems 3gAllergy™ Food Panel 3 10385891Recalls & reported problems

Siemens Healthcare Diagnostics Products Ltd · Food Panel 3 - IMMULITE - RGT - 40 test · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Oct 6, 2025Class IIOpen, Classified

    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.

    Z-0493-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Other SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL devices

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Sources and updates

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