Last update: August, 2024
Keeping you informed on the latest BD Vacutainer® Specimen Management Portfolio updates
We understand the important role that our BD Vacutainer® products play in ensuring accurate diagnostic test results for your patients, while also instilling safety and confidence in your clinical personnel. That’s why we have continuously made changes and improvements to our products over the years following their initial U.S Food and Drug Administration (FDA) clearance.
To demonstrate the continued performance of the BD Vacutainer® products since our prior filings with the FDA, BD is conducting both clinical and non‐clinical studies and updating 510(k) submissions for several BD Vacutainer® product families (premarket notification to gain updated FDA clearance). This process will result in changes to the Instructions for Use (IFU) and sometimes to the product indications.
This page provides links to the latest electronic IFUs and to the summary of changes for each relevant product family. To access all other eIFUs, please visit eifu.bd.com.
To stay updated with new releases, periodically return to this website to review these important additions.
Important updates to BD Vacutainer® Blood Collection Tubes
BD Vacutainer® ACD A and B Blood Collection Tubes
| Summary of changes letter | Instructions for use |
| 364606 | BD Vacutainer® glass whole blood ACD A Tube, 16x100 mm, 8.5 mL |
| 364816 | BD Vacutainer® glass whole blood ACD B Tube, 13x100 mm, 6.0 mL |
BD Vacutainer® Trace Element Tubes
| Summary of changes Letter (March 2024) | Summary of changes Letter (September 2023) | Instructions for Use |
| 368380 | BD Vacutainer® Trace Element Serum Blood Tube, 13x100 mm, 6.0 mL, Royal Blue Closure |
| 368381 | BD Vacutainer® Trace Element K2 EDTA (K2E) 10.8mg Tube, 13x100 mm, 6.0 mL, Royal Blue Closure |
| 367777 | BD Vacutainer® Trace Element K2 EDTA (K2E) 5.4 mg Tube, 13x75 mm, 3.0 mL, Royal Blue Closure (New SKU Available as of January 2024) |
| Discontinued product |
| 367855 | BD Vacutainer® K2E EDTA (K2E) 5.4 mg Blood Collection Tube, 13x75 mm, 3.0 mL, Tan Closure | Discontinued as of July 1, 2024, alternative: 367777 |
BD Vacutainer® EDTA Tubes
| Clearance letter | Summary of changes letter | Instructions for use |
| 367841 | BD Vacutainer® K2E (EDTA) 3.6 mg Blood Collection Tube, 13x75 mm, 2.0 mL, Lavender Closure |
| 367856 | BD Vacutainer® K2E (EDTA) 5.4 mg Blood Collection Tube, 13x75 mm, 3.0 mL, Lavender Closure |
| 367861 | BD Vacutainer® K2E (EDTA) 7.2 mg Blood Collection Tube, 13x75 mm, 4.0 mL, Lavender Closure |
| 367863 | BD Vacutainer® K2E (EDTA) 10.8 mg Blood Collection Tube, 13x100 mm, 6.0 mL, Lavender Closure |
| 366450 | BD Vacutainer® K3E (EDTA) 12.15 mg Blood Collection Tube, 13x100 mm, 7.0 mL, Lavender Rubber Stopper |
| 366643 | BD Vacutainer® K2E (EDTA) 18 mg Blood Collection Tube, 16x100 mm, 10.0 mL, Lavender Closure |
| 367842 | BD Vacutainer® K2E (EDTA) 3.6 mg Blood Collection Tube, 13x75 mm, 2.0 mL, Pink Closure |
| 367899 | BD Vacutainer® K2E (EDTA) 10.8 mg Blood Collection Tube, 13x100 mm, 6.0 mL, Pink Closure |
BD Vacutainer® Fluoride Tubes
| Clearance letter | Instructions for use |
| 367587 | BD Vacutainer®Sodium Fluoride: 3 mg Na2EDTA: 6 mg Blood Collection Tube, 2.0mL | 510(k) Cleared Indications for Use Labeling update |
| 367921 | BD Vacutainer®Sodium Fluoride 5 mg Potassium Oxalate 4 mg (FX) Blood Collection Tube, 2.0mL | 510(k) Cleared, Indications for Use, Labeling update |
| 367922 | BD Vacutainer®Sodium Fluoride 10 mg Potassium Oxalate 8 mg (FX) Blood Collection Tube, 4.0mL | 510(k) Cleared, Indications for Use, Labeling update |
| 367925 | BD Vacutainer®Sodium Fluoride 15 mg Potassium Oxalate 12 mg (FX) Blood Collection Tube, 6.0mL | 510(k) Cleared, Indications for Use, Shelf-life change, Labeling update |
| Discontinued product |
| 368587 | BD Vacutainer® Sodium Fluoride 10 mg Potassium Oxalate 8 mg (FX) Blood Collection Tube, 4.0mL | Discontinued as of October 1, 2024, alternative: 367922 |
| 368033 | BD Vacutainer® Sodium Fluoride: 10 mg Potassium Oxalate: 8 mg Blood Collection Tube, 4.0mL | Discontinued as of October 1, 2024, alternative: 367922 |
| 367729 | BD Vacutainer® Sodium Fluoride: 30 mg Blood Collection Tube, 7.0mL | Discontinued as of October 1, 2024, alternative: 367925 |
BD Vacutainer® SST™ Tubes
| Summary of changes letter |
| 367977 | BD Vacutainer® SST™ Blood Collection Tube, 13x100mm, 4.0mL, Paper Label | |
| 367983 | BD Vacutainer® SST™ Blood Collection Tube, 13x75mm 3.5ml. Paper Label | |
| 367986 | BD Vacutainer® SST™ Blood Collection Tube, 13x100mm, 5.0mL, Paper Label | |
| 367988 | BD Vacutainer® SST™ Blood Collection Tube, 16x100mm, 8.5mL, Paper Label | |
| 367989 | BD Vacutainer® SST™ Blood Collection Tube, 13x100mm, 5.0mL, Mylar Label | |
| 368013 | BD Vacutainer® SST™ Blood Collection Tube, 13x100mm, 5.0mL, Barcode Label | |
| 368015 | BD Vacutainer® SST™ Blood Collection Tube, 13x75mm, 3.5mL, Barcode Label | |
| 368016 | BD Vacutainer® SST™ Blood Collection Tube, 16x100mm, 8.5mL, Barcode Label | |
| 367990 | BD Vacutainer® SST™ Blood Collection Tube, 16x125mm, 10.0mL, Paper Label | (New SKU Available as of September, 2024) |
| Discontinued product |
| 367985 | BD Vacutainer® SST™ Blood Collection Tube, 16x125mm, 10.0mL, Paper Label | Discontinued as of November 1, 2024, alternative: 367990 |
BD Vacutainer® Tubes without additives
| EST Tube customer letter |
| Discontinued product |
| 362725 | BD Vacutainer® EST Z (No Additive) Blood Collection Tube, 3.0mL | Discontinued as of December 1, 2024, alternative: 366703 |
Important updates to BD Vacutainer® Specimen Acquisition Products
BD Vacutainer® Luer-Lok™ Access Device
| Summary of changes letter | Instructions for Use |
| 36490200 | BD Vacutainer® Luer-Lok™ Access Device |
BD Vacutainer® Blood Transfer Device
| Summary of changes Letter | Instructions for Use |
| 36488000 | BD Vacutainer® Blood Transfer Device |
BD Vacutainer® UltraTouch™ Push Button Blood Collection Set
| Summary of changes Letter | Instructions for Use |
| 367363 | BD Vacutainer® UltraTouch™ Push Button Blood Collection Set, 25G, 12” tubing |
| 367364 | BD Vacutainer® UltraTouch™ Push Button Blood Collection Set, 23G, 12” tubing |
| 367365 | BD Vacutainer® UltraTouch™ Push Button Blood Collection Set, 21G, 12” tubing |
BD Vacutainer® UltraTouch™ Push Button Blood Collection Set with Pre-Attached Holder
| Summary of changes letter | Instructions for use |
| 368687 | BD Vacutainer® UltraTouch™ Push Button Blood Collection Set with Preattached Holder, 25G, 12” tubing |
| 368688 | BD Vacutainer® UltraTouch™ Push Button Blood Collection Set with Preattached Holder, 23G, 12” tubing |
| 368689 | BD Vacutainer® UltraTouch™ Push Button Blood Collection Set with Preattached Holder, 21G, 12” tubing |
BD Vacutainer® Push Button Blood Collection Set
| Summary of changes letter | Instructions for use |
| 367341 | BD Vacutainer® Push Button Blood Collection Set, 25G, 12” tubing |
| 367342 | BD Vacutainer® Push Button Blood Collection Set, 23G, 12” tubing |
| 367344 | BD Vacutainer® Push Button Blood Collection Set, 21G, 12” tubing |
| 367324 | BD Vacutainer® Push Button Blood Collection Set, 23G, 12” tubing, w/o Luer Adapter |
BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder
| Summary of changes letter | Instructions for use |
| 367352 | BD Vacutainer® Push Button Blood Collection Set with Preattached Holder, 21G, 12” tubing |
| 368656 | BD Vacutainer® Push Button Blood Collection Set with Preattached Holder, 23G, 12” tubing |
| 368659 | BD Vacutainer® Push Button Blood Collection Set with Preattached Holder, 25G, 12” tubing |
Important updates to BD Vacutainer® Urine Collection Products
BD Vacutainer® Urinalysis Preservative Tubes
| Summary of changes letter | Instructions for Use |
| 364992 | BD Vacutainer® Urinalysis Preservative Tube, 16x100mm, 8.0mL |
| 365017 | BD Vacutainer® Urinalysis Preservative Tube, 16x100mm, 8.0mL |
BD Vacutainer®Urine Collection Kits
| Summary of changes letter | Instructions for Use |
| 364943 | BD Vacutainer® Urine Collection Kit, Urinalysis Transfer Straw Kit |
| 364946 | BD Vacutainer® Urine Collection Kit, Urinalysis Cup Kit |
| 364957 | BD Vacutainer® Urine Collection Kit, Complete Kit |
