Reported Oct 6, 2021 · Terminated
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634,…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
DxA 5000 (DxA Automation SystemDxA 5000 fit)"For in Vitro Diagnostic Use"
- Reference NumbersB87352 with B57634
- UDI15099590707118
- Lot codes and dates
- Affected US Serial Numbers
76 of 76 codes
T23000077T23000075T23000076T23000074T23000069T23000070T23000066T23000099T23000096T23000098T23000100T23000095T23000097T23000101T23000092T23000091T23000090T23000142T23000045T23000040T23000039T23000038T23000152T23000154T23000155T23000153T23000106T23000108T23000107T23000109T23000128T23000124T23000125T23000126T23000115T23000116T23000113T23000112T23000117T23000114T23000132T23000133T23000131T23000134T23000064T23000065T23000063T23000062T23000163T23000164T23000162T23000173T23000169T23000161T23000138T23000136T23000137T23000094T23000093T23000135
- Affected US Serial Numbers
- Amount recalled
- 123 systems
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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