Recall Z-1378-2021

Reason for recall

Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment

FDA-determined cause: Under Investigation by firm

Action taken

BD issued Urgent Medical Device Correction letter on 3/17/21 to customers and distributors via FedEx tracked letter. Letter states reason for recall, health risk and action to take: 1.Immediately inspect your inventory for the specific catalog and lot numbers listed above. Destroy all products subject to the recall following your institutions process for destruction. 2.Share this recall notification with all users within your facility network to ensure they are also aware of this recall. 3.Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement, if required. BD will provide a product replacement for all destroyed inventory. If you require further assistance, please contact: BD Contact US Contact Information Outside of US BD Customer/ Technical Support 800-638-8663 Monday Friday 7:00am and 7:00pm EST For customers outside the US, contact the local BD representative or distributor.