Z-2333-2019Class II

Kit BD Max StaphSR; Catalog # 443419

Name: Z-2333-2019 Kit BD Max StaphSR; Catalog # 443419
Creator: Becton Dickinson & Co.
Published: 2019-07-17
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-07-17 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of Kit BD Max StaphSR; Catalog # 443419 on 2019-07-17. FDA classified it as Class II and gives the reason as "The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2333-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-17
Posted: 2019-08-22
Terminated: 2020-05-13
Recalling firm: Becton Dickinson & Co
Product: Kit BD Max StaphSR; Catalog # 443419
Product code: NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Reason for recall: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 1. Thoroughly inspect all foil bags prior to use. If any of the foil bags in your inventory contain holes, dispose of the product and note the quantity in the attached Customer Response Form in order to request replacement. 2. Even if you do not have inventory of the product listed, complete the attached Customer Response Form and return to the BD contact noted on the form so that BD may acknowledge your receipt of this notification. 3. Share this Advisory Letter with all users of the BD MAX instrument within your facility to ensure awareness. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDAs MedWatch Adverse Event Reporting program. Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 BD Customer/Technical Support, 800-638-8663 Monday Friday between 7:00am and 7:00pm (EST) in the United States. For customers outside the US, contact your local BD representative or distributor.
Quantity in commerce: 207 units
Distribution: AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan
Product codes and lots: Lot # 9086668; ; UDI (GTIN, DI+PI) : (01)00382904434199 (17)200902(10)9086668(30)1; Exp :9/2/2020 Lot # 9092724; UDI (GTIN, DI+PI) :(01)00382904434199 (17)200902(10)9092724(30)1; Exp: 9/2/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2333-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2321-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2322-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2323-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2324-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2325-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2326-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2327-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2328-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2329-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2330-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2331-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2332-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2333-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2334-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2335-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2336-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2337-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2338-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2339-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22

Product code NQX

K132822Class IIBd Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) / cleared 2013-11-26

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)