Recall Z-0095-2023 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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.
| Date | Oct 14, 2022 (initiated Sep 15, 2022) |
| Status | Open, Classified |
| 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, adju |
| Quantity | 2,196,000 |
| Distribution | Distribution US nationwide, Canada, New Zealand, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.