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Terminated

Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.

FDA Recall Z-1741-2020 · Posted None

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2019-05-17
Date Terminated2022-03-11
Product Quantity291 units

Reason for Recall

Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing.

Firm Action

The recalling firm issued letters dated 5/8/2019 on 5/17/2019 informing the customers of the issue and that a spilled sample could lead to exposure of biohazardous material and that a software update would be made by their field service engineers at the next service call.

Root Cause

Software design

Distribution Pattern

Distribution was made to AL, CA, CO, DE, FL, GA, IL, IN, LA, MA, MD, MI, NC, ND, NJ, NY, OH, OR, PA, SD, TN, TX, and WA. There was government distribution and no military distribution. Foreign distribution was made to Argentina, Australia, Canada, China, Czech Republic, Egypt, France, Germany, India, Italy, Republic of Korea, Kuwait, Malaysia, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Taiwan, Turkey, UAE, United Kingdom, and Viet Nam.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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