FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Vacutainer Specimen Collection Cups, Cat. No. 364975
- Recall number
- Z-0492-2019
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Vacutainer Specimen Collection Cups, Cat. No. 364975
- Status
- Terminated
- Initiated
- 2018-08-30
- Posted
- not on file
- Terminated
- 2020-10-21
- Reason
- BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.
- Root cause
- Under Investigation by firm
- Action
- On August 30, 2018, BD notified Sysmex via an emailed Urgent Medical Device Product Safety Alert letter. Sysmex was informed that BD had confirmed the product issue with BD Vacutainer Urine Collection Cups were used with Sysmex UF Series Analyzers. Sysmex was instructed to take the following actions: - Notify Sysmex customers of the potential for elevation of RBC counts - Complete the customer Resopnse form and email it to BD at Gail_Griffiths@bd.com to confirm receipt of the Safety Alert. Product will continue to ship so as to not impact critical patient care. BD recommends following Good Clinical Practice (GCP) by performing microscopy to confirm an elevated RBC Count in a urine sample as per CLSI GP16-3A.29(4) and CAP Checklist on Urinalysis.
- Quantity
- Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS)
- Distribution
- Illinois
- Lot, serial or model codes
- All lots within expiry
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTW
- 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