Z-2067-2021Class II

Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack...

Name: Z-2067-2021 Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack...
Creator: Mercedes Medical, Inc.
Published: 2021-06-10
License: https://open.fda.gov/license/

Mercedes Medical LLC / initiated 2021-06-10 / Terminated

FDA source

Mercedes Medical, Inc. began a recall of 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 on 2021-06-10. FDA classified it as Class II and gives the reason as "No 510(k) clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2067-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-10
Posted: 2021-07-12
Terminated: 2023-08-14
Recalling firm: Mercedes Medical LLC
Product: 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.
Product code: QBD Microbial Nucleic Acid Storage And Stabilization Device
Reason for recall: No 510(k) clearance
FDA 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 in commerce: 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, Wisconsin, and Puerto Rico. The country of Bahamas. Government distribution was made but no military distribution.
Product codes and lots: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2067-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2066-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2067-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-21	2021-07-12

Product code QBD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)