BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium… recallZ-0095-2023 · Becton Dickinson & Company · initiated Sep 15, 2022

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Component design/selection

What the company is doing

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]

Recall details

Recall number: Z-0095-2023
Status: Open, Classified
Initiated by the company: Sep 15, 2022
Posted by the FDA: Oct 14, 2022
Recalling firm: Becton Dickinson & Company
Quantity: 2,196,000
Product code: JKA
Distribution: Distribution US nationwide, Canada, New Zealand, and Hong Kong.

Product description

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.

Code information (models, lots, serial numbers)

UDI-DI: Case: 50382903670012; Shelf: 30382903670018; Each: 00382903670017; ALL LOTS are affected.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

BD Vacutainer® Blood Alcohol Determinations Tube 367001
Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
2 recalls51 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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