NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Check against the official notice below — it lists the full affected range.
bioMerieux, Inc. is recalling 1,301 kits of NUCLISENS easyMAG Magnetic Silica (REF 280133, 24 x 1.2mL bottles per kit) due to contamination of extraction reagents that could result in no test result or a delayed result. The affected kits were distributed across 24 U.S. states: Arkansas, Arizona, California, Connecticut, Florida, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, and Virginia.
The recalled lot numbers are Z012MK1MS (expiration 28-NOV-2022), Z012ML1MS (expiration 28-NOV-2022), Z012NB1MS (expiration 28-DEC-2022), and Z013AL1MS (expiration 28-JAN-2023). The UDI is 03573026139339. The source document does not specify what consumers should do with affected kits.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
Reason for recall: There is a potential of no result leading to possible delayed result due to contamination of extraction reagents. Distribution: 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. Quantity: 1,301 kits Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.