MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 OAK MIX SPECIFIC ALLERGEN; SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer indicated that the immulite 2000 oak mix specific allergen lot 627 was scanned using a zebra barcode scanner and was loaded onto an immulite 2000 xpi instrument.The customer confirmed that immulite 2000 oak mix specific allergen lot 627 is not in use.The customer did not provide any patient data and did not indicate that erroneous patient results were obtained.However, if the order of tubes within the allergen holder wedge is incorrect there is a potential for patient sample results to be inaccurate for any allergen loaded in the same allergen holder wedge as immulite 2000 oak mix specific allergen lot 627.It is unknown if other allergen tubes were loaded in the same allergen holder wedge which were tested/reported.There are no known reports of patient intervention or adverse health consequences.
Additional Manufacturer Narrative
A united states (us) customer indicated that the immulite 2000 oak mix specific allergen lot 627 was scanned using a zebra barcode scanner and was loaded onto an immulite 2000 xpi instrument.Siemens advised the customer to remove immulite 2000 oak mix specific allergen lot 627 from their instrument.The customer stated that the allergen was onboard, but not in use.On 06-oct-2025 an urgent medical device correction (umdc, letter imc26-01.A.Us) was sent to the us customer.The umdc explained that barcode orientation on the immulite 2000 oak mix specific allergen lot 627 causes incorrect scanning order of tubes within the allergen holder wedge and there is a potential for patient sample results to be inaccurate for any allergen loaded in the allergen holder wedge.The customer was advised to discontinue use and discard the product.

• Brand Name: IMMULITE 2000 OAK MIX SPECIFIC ALLERGEN
• Common Device Name: SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: karen confort ; 333 coney st.; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 23352997
• Report Number: 1219913-2025-00191
• Device Sequence Number: 21046152
• Product Code: DHB
• UDI-Device Identifier: 00630414965970
• UDI-Public: (01)00630414965970(10)627(17)270831
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10386105
• Device Lot Number: 627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: CRR 1219913-10/14/2025-0
• Patient Sequence Number: 1
• Patient Sex: Unknown