Z-1377-2021Class II

BD BBL Martin-Lewis Agar, 100 Ea -

Name: Z-1377-2021 BD BBL Martin-Lewis Agar, 100 Ea -
Creator: Becton Dickinson & Co.
Published: 2021-03-17
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2021-03-17 / Terminated

FDA source

Becton Dickinson & Co. began a recall of 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... on 2021-03-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1377-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-17
Posted: 2021-04-08
Terminated: 2022-08-05
Recalling firm: Becton Dickinson & Co
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
Product code: JTY Culture Media, For Isolation Of Pathogenic Neisseria
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 root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 15550 EA
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1377-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1377-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-08
Z-1378-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-08

Product code JTY

K770287Class IIMartin-Lewis Agar MediumGibco Laboratories Life Technologies, Inc. / cleared 1977-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)