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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE 2000/IMMULITE 2000 XPi 3gAllergy Specific lgE

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  Class 2 Device Recall IMMULITE 2000/IMMULITE 2000 XPi 3gAllergy Specific lgE see related information
Date Initiated by Firm November 04, 2022
Date Posted December 15, 2022
Recall Status1 Open3, Classified
Recall Number Z-0717-2023
Recall Event ID 91164
510(K)Number K101572  
Product Classification System, test, radioallergosorbent (rast) immunological - Product Code DHB
Product IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan
Siemens Material Number (SMN): 10380875

For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
Code Information UDI:-DI: (01)00630414962269(10)826(17)20221130; (01)00630414962269(10)830(17)20221130; (01)00630414962269(10)831(17)20221130; (01)00630414962269(10)832(17)20221130; (01)00630414962269(10)833(17)20221130. Kit Lots: 826, 830, 831,832, 833
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact SAME
508-668-5000
Manufacturer Reason
for Recall		 Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens initiated issued on 11/04/2022 an Urgent Medical Device Correction (UMDC) IMC 23-01.A.US to US customers, an Urgent Field Safety Notice (UFSN) IMC 23-01.A-1.OUS to Outside the US (OUS, except Japan) customers, and an Urgent Field Safety Notice (UFSN) IMC 23-01.A-2.OUS (Japan) to customers in Japan . Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. Discontinue use of the kit lots listed in Table 1. Review your inventory of this product to determine your laboratory s replacement needs and to provide information to Siemens for reporting to the authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative
Quantity in Commerce 5,193 kits
Distribution Worldwide distribution. US Nationwide, Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Azerbaijan¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Brazil¿¿¿¿¿¿¿¿¿ Chile¿¿¿¿¿¿¿¿¿¿ Colombia¿¿¿¿¿¿¿ Costa¿Rica¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Ecuador¿¿¿¿¿¿¿¿ Egypt¿¿¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Guatemala¿¿¿¿¿¿ Hong¿Kong¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Indonesia¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿ Japan¿¿¿¿¿¿¿¿ Latvia¿¿¿¿¿¿¿¿¿ Lithuania¿¿¿¿¿¿ Macedonia¿¿¿¿¿¿ Mexico¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ Norway¿¿¿¿¿¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Panama¿¿¿¿¿¿¿¿¿ Paraguay¿¿¿¿¿¿¿ Philippines¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Russian¿Fed.¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ South¿Africa¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Sweden¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Taiwan¿¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ Ukraine¿¿¿¿¿¿¿¿ United¿Kingdom¿ Uruguay, and Uzbekistan¿¿¿¿¿
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DHB and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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