FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
- Recall number
- Z-2602-2021
- Recalling firm
- Beckman Coulter Inc.
- Product
- DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
- Status
- Terminated
- Initiated
- 2021-07-21
- Posted
- not on file
- Terminated
- 2024-10-10
- Reason
- There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped when they reach the end of the outer lane which could result in Delay in providing patient with appropriate medical treatment. New sample needs to be drawn. Substantial discharge of biohazards material - Infection with a human transmissible blood-borne or animal pathogen which could result in Infection with a human transmissible blood-borne pathogen (e.g. infectious HBV, HCV, HIV).
- Root cause
- Under Investigation by firm
- Action
- On August 9 & 11, 2021 Beckman Coulter issued a "Urgent Medical Device Recall" Notification via: E-Mail and paper mail. In addition, to informing consignee about the recall device, the firm ask consignees to take the following actions: 1. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. 2. If the DxA System is observed to be routing sample carriers to the outer lane of the Single Drive Transport Segment (B57634), please report your observation to Beckman Coulter. 3. When conducting maintenance or trouble-shooting sample carriers on the DxA transport system, follow the instructions as given in the DxA Instructions for Use, especially with respect to correctly remove and re-introduce sample tubes. Please note that there is the option to set up the delayed sample tracking function in Remisol Advance Software, that alerts the user to potentially impacted samples. Please refer to the chapter "dashboard & reporting - tracking of delayed samples in Remisol" in the Instruction for Use of Remisol Advance. 4. Beckman Coulter will be providing a physical stopper solution to be installed on the single drive segment by Beckman coulter Service or authorize Field Service Engineers. 5. Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication. 6. If you have any questions regarding this notice, please contact our customer Support Center via our website: http://www.beckmancoulter.com. 7. In case you experience adverse reactions or quality problems with the use of this product you may report them to the FDA s MedWatch Adverse Event Reporting program (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program ) in addition to reporting to Beckman Coulter via our website: http://www.beckmancoulter.com or your local Beckman Coulter representative by phone.
- Quantity
- 123 systems
- Distribution
- US Nationwide distribution in the states of AL, CA, IL, In, KY, MN, MI, OH, PA, TX, WV.
- Lot, serial or model codes
- Affected US Serial Numbers: T23000077, T23000075, T23000076, T23000074, T23000069, T23000070, T23000066, T23000099, T23000096, T23000098, T23000100, T23000095, T23000097, T23000101, T23000092, T23000091, T23000090, T23000142, T23000045, T23000040, T23000039, T23000038, T23000152, T23000154, T23000155, T23000153, T23000106, T23000108, T23000107, T23000109, T23000128, T23000124, T23000125, T23000126, T23000115, T23000116, T23000113, T23000112, T23000117, T23000114, T23000132, T23000133, T23000131, T23000134, T23000064, T23000065, T23000063, T23000062, T23000163, T23000164, T23000162, T23000173, T23000169, T23000161, T23000138, T23000136, T23000137, T23000094, T23000093, T23000135, T23000141, T23000139, T23000140, T23000166, T23000168, T23000167, T23000082, T23000081, T23000080, T23000085, T23000084, T23000083, T23000143, T23000146, T23000145, T23000144
- 510(k) numbers
- ["K190298"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- 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