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Open, Classified

NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection Note: Results for targets other than SARS-CoV-2 are not impacted by this Urgent Medical Device Correction Ref. Number: 100100

FDA Recall Z-1000-2022 · Posted None

Recalling FirmNeuMoDx Molecular Inc
Recall StatusOpen, Classified
Product CodeQJR
Date Initiated2022-02-18
Product Quantity773 (72 US and 701 ROW) cases (48 cartridges/case)

Reason for Recall

Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900) result incorrect management of patients

Firm Action

QIAGEN issued customer Urgent Medical Device Correction notification via email firstly by English (then in local language if required)on 2/18/22. Letter states reason for recall, health risk and action to take: 1. IMMEDIATELY discontinue use of the product and discard remaining inventory in accordance with your national and local safety and environmental regulations. Please contact QIAGEN Technical Service for a free-of-charge replacement of scrapped inventory. 2. Share this Field Safety Corrective Action with all users of the NeuMoDx Cartridges in your facility to ensure they are aware of this notice. 3. If you have already used NeuMoDx Cartridges from any of these lots in combination with the NeuMoDx SARS-CoV-2 Assay, the NeuMoDx Flu-A-B/RSV/SARS-CoV-2 Assay and NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection please review all SARS-CoV-2 positive results to exclude erroneous diagnosis and treatment, except in those cases where alternative confirmation was obtained. Note: results for targets other than SARS-CoV-2 are not impacted by this Urgent Field Safety Corrective Action. 4. Complete the attached response form and return to [email protected] to confirm receipt of this notification. If you have any questions regarding this notice, please contact QIAGEN Technical Services at 1-800-362-7737 or [email protected]

Root Cause

Material/Component Contamination

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of OH, MO, VA, MI, MI, FL, MD, IA, NY, MO and the countries of Italy, Germany, Switzerland, Sweden, Netherlands, Finland, Spain, United Kingdom, Belgium, Austria, Hong Kong, France, Denmark, Slovenia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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