Recall Z-1564-2022 ยท PPM General Purpose Reagent
bioMerieux, Inc.
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
| Date | Jul 20, 2022 |
| Status | Open, Classified |
| Reason | There is a potential of no result leading to possible delayed result due to contamination of extraction reagents. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued undated letters with a reference number of FSCA#5690 via overnight mail on 7/20/2022. The letter explained the issue and instructed the customers to distribute the information to all appropriate personnel in their laboratory and forward the information to all parties that may use the product, including others to whom the customer may have transferred the product. They are informed they can continue to use the impacted lots of the NUCLISENS Magnetic Silica Ref 280133 listed in Table 1 except for bacterial nucleic acid detection applications, especially Legionella spp |
| Quantity | 1,301 kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.