Recall StatusOpen, Classified
Date Initiated2023-05-31
Product Quantity1,296 packs
Reason for Recall
The test medium may not perform as intended.
Firm Action
The firm issued recall letters dated 5/31/2023 via mail on 5/31/2023 that were flagged as URGENT: Deliver to Micro Lab. The letter provides the reason for the field action, risk to health, the product and distribution information, and actions to be taken by the customer. The actions included the consignee review reported results by an appropriate technical expert. The letter should be passed onto all who need to be aware within the consignee's organization or to any organization where the affected products have been transferred. An Acknowledgement Form was enclosed for return to the firm via email. The form is for the consignee to acknowledge receipt of the recall notice and that it is understood, and the information and required actions have been brought to the attention of all relevant users and executed. The deadline for returning the form is 6/30/2023.
Root Cause
Under Investigation by firm
Distribution Pattern
Distribution was made nationwide, including Puerto Rico. There was no foreign or military distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.