Z-0854-2022 Class II
FDA device recall Z-0854-2022 was initiated by Illumina, Inc. on February 22, 2022 and is designated Class II. Reason for recall: There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon… Affected quantity: 674 instruments.
Recall Details
- Product Type
- Devices
- Report Date
- April 6, 2022
- Initiation Date
- February 22, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 674 instruments
Product Description
Reason for Recall
Distribution Pattern
US: PA, WA, CA, MI, FL, MD, AR, UT NC, Fl, IL, NE, NJ, TN, NY, IN, CO, GA, OK, TX, CT, SD, NM, VA, AL, LA, SC, WV, OR, IA, AZ, MN OUS: Australia Austria Belgium Chile China Denmark Finland France Germany Hungary Ireland Italy Japan Latvia Netherlands Norway Poland Portugal Romania Russian Federation Saudi Arabia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom Vietnam