Recall Z-0492-2026 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
Siemens Healthcare Diagnostics, Inc.
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;
| Date | Nov 13, 2025 (initiated Oct 6, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 Corre |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101572 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT Siemens Healthcare Diagnostics, Aug 1, 2011 |