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

Company

North American Diagnostics

Recall Initiated

June 15, 2022

Recall Number

Z-1401-2022

Quantity

122,366 units

Firm Location

Holly Hill, FL

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.

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.

Lot / Code Info

Lot: FLUSA 1020-1, Batches 8, 10, and 12

Root Cause

No Marketing Application

Action Taken

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.