Recall Z-0492-2026
Siemens Healthcare Diagnostics, Inc. · initiated October 6, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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;
Codes / lots: Siemens Material Number (SMN): 10380875; Model/Catalog: L2KUN6; UDI-DI: 00630414962269; Lot number: 169, 170, 171, 172;
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
On October 6, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer Actions Perform the instructions provided below: " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " Discontinue use of and discard IMMULITE 2000 Oak Mix Specific Allergen Lot 627. " Review your inventory of the product to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 7 days. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution The issue is resolved with the next available lot of IMMULITE 2000 Oak Mix Specific Allergen. It is anticipated that the replacement lot will be available by mid-November 2025. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Custom
Details
- Recall number
- Z-0492-2026
- Initiated
- October 6, 2025
- Posted by FDA
- November 13, 2025
- Product code
- DHB – System, Test, Radioallergosorbent (Rast) Immunological
- Quantity
- 2802 units (OUS only)
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., East Walpole, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0491-2026 Class II | IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105…The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen… | 10/06/2025Open, Classified |
| Z-0493-2026 Class II | Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number:…The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen… | 10/06/2025Open, Classified |