—#197091

Product

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

FDA product code: DHB — System, Test, Radioallergosorbent (Rast) Immunological
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K101572
Affected lot / code info: UDI:-DI: (01)00630414278735(10)565(17)20221130 Kit Lot 565

Why it was recalled

Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: 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¿¿¿¿¿

Timeline

Recall initiated: 2022-11-04
Posted by FDA: 2022-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197091. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.