FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
- Recall number
- Z-0889-2026
- Recalling firm
- Beckman Coulter, Inc.
- Product
- Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
- Status
- Open, Classified
- Initiated
- 2025-11-07
- Posted
- 2025-12-09
- Terminated
- not on file
- Reason
- It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
- Root cause
- Process design
- Action
- An URGENT MEDICAL DEVICE RECALL notification letter dated 10/29/25 was sent to customers. Check your inventory of Access 2 RVs for the lots listed at the top of this letter. "If you have the lots listed above contact Beckman coulter for replacement RVs. "You may continue to use the lots listed above until you have received a sufficient supply of replacement RVs. Once replacement RVs arrive, then dispose of the lots listed above according to your local regulations. "If you do not have the RV lots listed above, then no further action is needed. Retrospective review of results is not necessary because this issue does not affect individual patient results. Please contact your local Beckman Coulter representative for replacement product requests. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: "Electronically, if you received this communication via email. "Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center: "From our website: http://www.beckmancoulter.com "Contact your local Beckman Coulter Representative for replacement.
- Quantity
- 38,225 untis
- Distribution
- US Nationwide. Global Distribution.
- Lot, serial or model codes
- UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005
- 510(k) numbers
- ["K121214"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2122870
- Firm city
- Chaska
- Firm state
- MN
- 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