Lingen Virus Sampling Kit (Mercedes Medical) – No 510(k) Clearance (2021)
Medical sampling kit lacking regulatory clearance can pose potential patient safety risks.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Mercedes Medical, Inc.
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Mercedes Medical, Inc. is recalling Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swab due to No 510(k) clearance. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
No 510(k) clearance
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026