FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: 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.
- Recall number
- Z-0095-2023
- Recalling firm
- Becton Dickinson & Company
- 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.
- Status
- Open, Classified
- Initiated
- 2022-09-15
- Posted
- 2022-10-14
- Terminated
- not on file
- Reason
- 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
- 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: productcomplaints@bd.com
- Quantity
- 2,196,000
- Distribution
- Distribution US nationwide, Canada, New Zealand, and Hong Kong.
- Lot, serial or model codes
- UDI-DI: Case: 50382903670012; Shelf: 30382903670018; Each: 00382903670017; ALL LOTS are affected.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28