Recall Z-1432-2021

Reason for recall

Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.

FDA-determined cause: Labeling False and Misleading

Action taken

On 03/02/2021, the firm sent an "URGENT: Medical Device Recall" Notification Letter via email or mail to customers informing them that Rapid Test kits were incorrectly labeled as "for diagnostic use" and labeled with an unsupported expiration date. Between 03/22-26/2021, the firm sent a revised/follow-up Recall Notification Letter via email. Customers are instructed to: -Remove any stock from inventory and to not further distribute the affected products until the issue is resolved and to return any unused inventory to Recall Firm at 5250 Gulfton Street, Suite 2C, Houston TX 77081. In addition, customer are informed: 1) The Recalling Firm is advising that Healthcare providers administering these tests remind their patients that the test is not a diagnostic test. 2) The Recalling Firm will replace the recalled inventory and do not anticipate any product shortages. The Recalling Firm is also instructing to review the attached Rework Instructions for details on how to rework the product for distribution. 3) Complete acknowledge receipt of this recall notification by emailing recall@azure.bio or returning the attached letter to ATTN: Recall Dept, Azure Biotech Inc., 5250 Gulfton Street, Ste 2C, Houston TX 77081. For additional questions and assistance, contact the Recalling Firm's Director at recall@azure.bio, or Customer Service at 1-800-618-5829 Monday through Friday 9:00 a.m. to 5:00 p.m. CST