Z-1683-2023 Class II Ongoing
FDA device recall Z-1683-2023 was initiated by Qiagen Sciences LLC on April 28, 2023 and is designated Class II. Reason for recall: Faulty cartridges in the lot could result in false test results. The recall status is ongoing. Affected quantity: 347 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2023
- Initiation Date
- April 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 347 kits
Product Description
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Reason for Recall
Faulty cartridges in the lot could result in false test results.
Distribution Pattern
US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.
Code Information
GTIN 14053228038846; Lot 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 330569651, 330569650, 330569646, 330569645, 330569644, 330569643, 330569641.