—#195971

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.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: UDI-DI: Case: 50382903670012; Shelf: 30382903670018; Each: 00382903670017; ALL LOTS are affected.

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Distribution US nationwide, Canada, New Zealand, and Hong Kong.

Timeline

Recall initiated: 2022-09-15
Posted by FDA: 2022-10-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195971. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.