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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE

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 Class 2 Device Recall IMMULITEsee related information
Date Initiated by FirmOctober 06, 2025
Date PostedNovember 13, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0493-2026
Recall Event ID 97819
510(K)NumberK021208 
Product Classification System, test, radioallergosorbent (rast) immunological - Product Code DHB
ProductFood Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
Code Information Siemens Material Number (SMN): 10385891; Model/Catalog: FP3L4; UDI-DI: 00630414960418; Lot number: 629;
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
333 Coney St
East Walpole MA 02032-1516
For Additional Information ContactKaren Confort
508-668-5000
Manufacturer 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 2		Under Investigation by firm
ActionOn 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
Quantity in Commerce28 units (OUS only)
DistributionWorldwide - 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 Fed., Serbia, Slovakia, Spain, Sweden, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DHB
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