Class 1 Device Recall Oral Rapid SARSCoV2 Rapid Antigen Test Kit

• Date Initiated by Firm: June 15, 2022
• Create Date: July 29, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1401-2022
• Recall Event ID: 90381
• Product Classification: Coronavirus antigen detection test system. - Product Code QKP
• Product: SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
• Code Information: Lot: FLUSA 1020-1, Batches 8, 10, and 12
• Recalling Firm/ Manufacturer: North American Diagnostics; 618 Ridgewood Ave; Holly Hill FL 32117-3604
• Manufacturer Reason for Recall: Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.
• FDA Determined Cause: No Marketing Application
• Action: The firm initiated their recall by email on 06/15/2022. The letter explained the issue and requested the consignee take the following actions: "" Immediately destroy all unused product to North American Diagnostics Inc. " Immediately identify all affected product in your inventory and segregate to avoid inadvertent use or further distribution. " Complete the attached response form and return it to Elizabeth Lashinsky ealash52@gmail.com. " If you have further distributed any of these products, please notify your customers immediately with a copy of this notice, and please request that your customers destroy any product they may have in inventory and confirm in writing that they have done so. " If you have relabeled the product prior to distributing it, please indicate the number below and the name on the label. If you have questions or concerns regarding this recall, or problems with the product, please contact Elizabeth A. Lashinsky, Manager, ealash52@gmail.com, 407-312-7104.
• Quantity in Commerce: 122,366 units
• Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, LA, NV, CA, CO, AZ, CT, OH. IL, NY, DC, MD, PA, and the countries of Zambia, Austria, Canada, UAE, Bangladesh.
• Total Product Life Cycle: TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.