Z-1564-2022 Class II Ongoing
FDA device recall Z-1564-2022 was initiated by bioMerieux, Inc. on Jul 20, 2022 and is designated Class II. Reason for recall: There is a potential of no result leading to possible delayed result due to contamination of extraction reagents. The recall status is ongoing. Affected quantity: 1,301 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2022
- Initiation Date
- Jul 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,301 kits
Product Description
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Reason for Recall
There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
Distribution Pattern
Distribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, TN, TX, and VA. There was no government/military distribution.
Code Information
Lot numbers distributed in the U.S.: Z012MK1MS, exp. 28-NOV-2022; Z012ML1MS, exp. 28-NOV-2022; Z012NB1MS, exp. 28-DEC-2022; Z013AL1MS, exp. 28-JAN-2023. UDI: 03573026139339.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1564-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026