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Beckman Coulter Inc. Recall 88339

Description: Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

Beckman Coulter Inc. Recall 88339 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2332-2021
Event ID88339
Event DescriptionNormand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of Al, CA, FL, GA, IL, IN, MA, NC, OH, PA, TN, TX and the countries of Australia, Belgium, Canada, China, Czech Republic, France, Italy, Netherlands, New Zealand, Poland, Russia, Switzerland, Taiwan, United Kingdom, United States, Zimbabwe.
Quantity180 units
Recall ReasonThere is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.
Device Classification20210901
Device Code InfoSoftware Version 2.0 and 2.1
Center Classification Date20210823
Recall Initiation Date20210715
Recalling FirmBeckman Coulter Inc.
Initial Notification Letter
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