The Recall Desk
HighFDA (Devices)·Z-0117-2022·Announced 2021-10-20

Beckman Coulter Power Processor 3K Recalled for Missing Splash Guard

Beckman Coulter is recalling Power Processor 3K laboratory equipment due to a missing splash guard that may expose users to hazardous materials. Approximately 271 units were distributed in the U.S. and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving a missing critical safety component (splash guard) that may expose laboratory workers to hazardous materials. The source text contains no reports of illnesses or injuries, making the hazard theoretical rather than confirmed. Per the severity rubric, risk-of-harm products without reported injury score 3 (High).

Plain-English summary

Beckman Coulter Inc. is recalling Power Processor 3K laboratory equipment (including 3K High Speed and 5K High Speed variants) due to a missing splash guard that may expose users to hazardous materials. The splash guard is a critical safety component designed to protect against exposure during laboratory specimen processing.

Approximately 271 affected units have been distributed across the United States and internationally, including in Canada, China, Spain, France, United Kingdom, Israel, Italy, South Korea, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Portugal, Qatar, Saudi Arabia, Thailand, Turkey, Taiwan, and South Africa. Within the U.S., distribution includes facilities in California, Georgia, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Mississippi, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington, and West Virginia.

The FDA has classified this as a Class II recall. Facilities and users with affected equipment should contact Beckman Coulter immediately to obtain a replacement splash guard or receive further instructions. Do not operate equipment if the splash guard is missing or damaged.

The recalled product

Product
Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Equipment
Hazard
  • missing-safety-component
  • chemical-exposure
  • splash-hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 90HF1306009
  • 90HF1303005
  • 90HF1508005
  • 90HF1302005
  • 90HF1610005
  • 90HF1806001
  • 90HF1209005
  • 90HF1303007
  • 90HF1708006
  • 90HF1205001
  • 90HF1805002
  • 90HF1402005
  • 90HF1503001
  • 90HF1104002
  • 90HF1208004
  • 90HF1208005
  • 90HF1203001
  • 90HF1012004
  • 90HF1101002
  • 90HF1702003

Distribution

Distributed nationwide across the United States.

Related recalls

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