FDA Device recall Z-1564-2022
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit
- FDA Device
- Class II
- ongoing
- Published 2022-08-31
On 2022-08-31 the FDA classified a Class II recall of NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit by Biomerieux, citing there is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1564-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-20 |
| Published | 2022-08-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomerieux |
| Distribution | AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, TN, TX, VA |
Product
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Reason
There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
Identifiers
| code_info | Lot numbers distributed in the U.S.: Z012MK1MS, exp. 28-NOV-2022; Z012ML1MS, exp. 28-NOV-2022; Z012NB1MS, exp. 28-DEC-…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1564-2022%22
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