Z-2602-2021 Class II Terminated
FDA device recall Z-2602-2021 was initiated by Beckman Coulter Inc. on July 21, 2021 and is designated Class II. 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. … The recall status is terminated (terminated October 10, 2024). Affected quantity: 123 systems.
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- July 21, 2021
- Termination Date
- October 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123 systems
Product Description
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
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).
Distribution Pattern
US Nationwide distribution in the states of AL, CA, IL, In, KY, MN, MI, OH, PA, TX, WV.
Code Information
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