Recall Z-2067-2021 ยท QBD Microbial Nucleic Acid Storage And Stabilization Device
Mercedes Medical, Inc.
Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
| Date | Jun 10, 2021 |
| Status | Terminated |
| Reason | No 510(k) clearance |
| Root cause | No Marketing Application |
| Action | Letters dated 5/25/2021 were issued via email on 6/10/2021 explaining the reason for recall and safety risks if the kits are used. Return of the kits was requested. A second letter dated 6/29/2021 was issued via email on 6/29/2021 which expanded the recall to include two additional item numbers that were inadvertently excluded from the original letter. The items were sample packs of the products previously recalled. |
| Quantity | SAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, Ne |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.