Device recall: IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Class II FDA enforcement event 97819. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Siemens Healthcare Diagnostics, Inc. started this device recall on 6 Oct 2025. The firm address in the FDA record is in East Walpole, MA. FDA put the recall in Class II. FDA event 97819 has 3 product records. The first FDA enforcement report date is 19 Nov 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
Siemens Healthcare Diagnostics, Inc., East Walpole, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0491-2026 | IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6; | 34 units (1 US, 33 OUS) | Class II | Ongoing | 19 Nov 2025 |
| 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; | 2802 units (OUS only) | Class II | Ongoing | 19 Nov 2025 |
| Z-0493-2026 | Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4; | 28 units (OUS only) | Class II | Ongoing | 19 Nov 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 333
Other events of the firm
Official channels
- FDA enforcement report Z-0491-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 97819. https://recallregister.com/fda/ii/97819/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 97819?
- The event has 3 product records. The first record gives this quantity:
34 units (1 US, 33 OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.