Device product
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Z-1564-2022
Product summary
- Firm
- bioMerieux, Inc.
- Event
- Event 90596
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,301 kits
- Official record key
device-enforcement:Z-1564-2022
Official wording
Reason: There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
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.
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.
Derived failure modes
-
Unknown
There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.