Z-2602-2021Class II

DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with...

Name: Z-2602-2021 DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with...
Creator: Beckman Coulter Inc.
Published: 2021-07-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-07-21 / Terminated

FDA source

Beckman Coulter Inc. began a recall of DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118 on 2021-07-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2602-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-21
Posted: 2021-09-30
Terminated: 2024-10-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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).
FDA 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 in commerce: 123 systems
Distribution: US Nationwide distribution in the states of AL, CA, IL, In, KY, MN, MI, OH, PA, TX, WV.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2602-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2602-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-30

Product code JJE

K190298Class IIDxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbH / cleared 2019-10-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)