—#186259

Product

BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558

FDA product code: JTY — Culture Media, For Isolation Of Pathogenic Neisseria
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K770287
Affected lot / code info: Lot Numbers: 0317559 Exp. Date 2021-MAR-11; 0345695 Exp. Date 2021-APR-06 UDI: 01)30382902215586 (10)0317559(17)031121 (30)0100 (01)30382902215586 (10)0345695(17)040621 (30)0100

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea.

Timeline

Recall initiated: 2021-03-17
Terminated: 2022-08-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186259. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.