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NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx… recallZ-1000-2022 · NeuMoDx Molecular Inc · initiated Feb 18, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from NeuMoDx Molecular Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Material/Component Contamination

What the company is doing

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]

Recall details

Recall number
Z-1000-2022
Status
Open, Classified
Initiated by the company
Feb 18, 2022
Recalling firm
NeuMoDx Molecular Inc
Quantity
773 (72 US and 701 ROW) cases (48 cartridges/case)
Product code
QJR
Distribution
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.

Product description

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

Code information (models, lots, serial numbers)

Lot Numbers: 115424, 115425, 115426, 115427, 115429, 115431. GTIN: 10814278020274

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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