DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Beckman Coulter Inc.
- 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).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2602-2021
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