Z-0095-2023Class II

BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting...

Name: Z-0095-2023 BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting...
Creator: Becton Dickinson & Company
Published: 2022-09-15
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2022-09-15 / Open, Classified / root cause: design

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for... on 2022-09-15. FDA classified it as Class II and gives the reason as "The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0095-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-15
Posted: 2022-10-14
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.
Root cause tag: design
FDA root cause: Component design/selection
Action: On September 15, 2022, the firm notified affected distributors and customers of the recall via Urgent Medical Device Product Advisory letters. Customers were instructed to do the following: 1. Inspect your inventory for the affected catalog number. 2. Ensure the contents of the Product Advisory are read, understood and shared with laboratory management staff having oversight over gas chromatography testing for methanol. Review internal method validations, and if applicable, adjust test practices or settings to avoid potential interference (e.g., implementing the tube as a blank/control, adjustment of GC column and/or operational settings to prevent co-elution, or conversion to dual-column system). 3. If the potential interference cannot be mitigated, stop using the BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg. Product may be returned for credit. The recalling firm will update the IFU to address the potential risk of interference from rubber stopper outgassing in gas chromatography methods. The firm has also initiated corrective and preventive action to investigate root cause and identify actions. If you have further questions, please contact the firm via Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: [email protected]
Quantity in commerce: 2,196,000
Distribution: Distribution US nationwide, Canada, New Zealand, and Hong Kong.
Product codes and lots: UDI-DI: Case: 50382903670012; Shelf: 30382903670018; Each: 00382903670017; ALL LOTS are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0095-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0095-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-14

Product code JKA

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)