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Terminated

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.

FDA Recall Z-2067-2021 · Posted None

Recalling FirmMercedes Medical, Inc.
Recall StatusTerminated
Product CodeQBD
Date Initiated2021-06-10
Date Terminated2023-08-14
Product QuantitySAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs

Reason for Recall

No 510(k) clearance

Firm 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.

Root Cause

No Marketing Application

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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