Z-0473-2023Class II

BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number...

Name: Z-0473-2023 BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number...
Creator: Becton Dickinson & Co.
Published: 2022-11-21
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2022-11-21 / Open, Classified

FDA source

Becton Dickinson & Co. began a recall of BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267 on 2022-11-21. FDA classified it as Class II and gives the reason as "Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0473-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-21
Posted: 2022-12-09
Recalling firm: Becton Dickinson & Co
Product: BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Product code: JTY Culture Media, For Isolation Of Pathogenic Neisseria
Reason for recall: Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.
FDA root cause: Under Investigation by firm
Action: BD initiated the recall on November 21, 2022 via Urgent Medical Device Correction Letter. to Distributors and Risk Managers. Letter states reason for recall, health risk and action to take: Immediately inspect your inventory for the specific catalog and lot number listed above. Affected product includes box numbers 0002 through 0097. These boxes correlate to timestamps on the plates of 11:34 through 13:51. Timestamps can be found on the bottom of the plate. The box number can be located on the 2. Share and post this recall letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 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. Distributors: As BD plans to notify all affected customers directly, please identify customers within your distribution network that purchased the affected product, as defined in this notification. Email an excel file listing of all customers to [email protected] within 72 hours of receipt of this letter so that BD may initiate customer notification. Actions Taken by BD: BD will issue replacements following receipt of the completed Customer Response Form. Questions: North American Regional Complaint Center .Phone: 1-844-8BD-LIFE (1-844-823-5433) Fri 8:00am and 5:00pm CT or Email: [email protected]
Quantity in commerce: 9,600 EA
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.
Product codes and lots: UDI: (10)2206461(17)221125(30)0100 Lot Number: 2206461 Exp. Date: 20221125. Box numbers 0002 through 0097. Boxes correlate to timestamps on the plates of 11:34 through 13:51. All other box numbers and plate stamps are unaffected and perform as intended. (Timestamps can be found on the bottom of the plate. The box number can be located on the carton label).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0473-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0473-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-09

Product code JTY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)