Beckman Coulter Inc.: The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.

Agency Publication Date: December 13, 2017

Affected Products

Product: UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer

Serial Numbers: B24802: AW10161, AW10154, AZ34449, AZ34447 629029: AT40563, AT06096, AT06095, AT02044, AW05080, AW05072, AW05066, AT50679, AS49422, AS36312, AS23151

Product: UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)

Serial Number AZ06682

Product: UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer

Serial Numbers: AW09034, AV40142, AU19113

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78611

Status: Resolved

Manufacturer: Beckman Coulter Inc.

Manufactured In: United States

Units Affected: 3 products (15 units; 1 unit; 3 units)

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Sources: FDA iRES · Raw API Response

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