Z-2596-2018 Class II Terminated
FDA device recall Z-2596-2018 was initiated by QIAGEN on May 28, 2018 and is designated Class II. Reason for recall: Underfilled reagent well that could lead to incorrect results The recall status is terminated (terminated April 5, 2019). Affected quantity: 287 pcs.
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2018
- Initiation Date
- May 28, 2018
- Termination Date
- April 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 287 pcs
Product Description
EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Reason for Recall
Underfilled reagent well that could lead to incorrect results
Distribution Pattern
Domestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA
Code Information
UDI - 04053228000099 Lot - 160020069 Expiration - 11/01/19