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U.S. Department of Health and Human Services

Class 2 Device Recall Lingen Disposable Virus Sampling Kit

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 Class 2 Device Recall Lingen Disposable Virus Sampling Kitsee related information
Date Initiated by FirmJune 10, 2021
Create DateJuly 12, 2021
Recall Status1 Terminated 3 on August 14, 2023
Recall NumberZ-2067-2021
Recall Event ID 88088
Product Classification Microbial nucleic acid storage and stabilization device - Product Code QBD
ProductLingen 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.
Code Information All lots.
FEI Number 1000442352
Recalling Firm/
Manufacturer		 Mercedes Medical, Inc.
12210 Rangeland Parkway
Lakewood Ranch FL 34211
For Additional Information ContactMisty McWhorter-Darley
941-355-3333 Ext. 110
Manufacturer Reason
for Recall		No 510(k) clearance
FDA Determined
Cause 2		No Marketing Application
ActionLetters 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 CommerceSAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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