Official recall record
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-10-06
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Siemens Healthcare Diagnostics, Inc.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL - 2026-07-06 · US FDA — Medical Devices
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All 29 official recall notices naming Siemens Healthcare Diagnostics, Inc. on this site →
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