The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-0308-2018·Announced 2018-01-10

Beckman Coulter Access 2 Immunoassay System Recalled for Burn Risk

Beckman Coulter is recalling Access 2 Immunoassay Systems due to a potential for minor skin burns if the tool contacts the reagent storage interface board during pipettor alignment.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is described as a potential for minor skin burns, which aligns with the 'Low' severity criteria for minor defects.

Plain-English summary

Beckman Coulter Inc. is recalling 227 units of the Access 2 Immunoassay System, Catalog Number 81600N. This in vitro diagnostic device is used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. The recall is classified as Class III by the FDA.

The recall is being issued because of a potential for minor skin burns if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment. The affected units were distributed worldwide, including in the United States, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.

Affected serial/lot numbers include 570005-570043, 570047-570049, 570051-570061, 570066-570071, 570073-570091, 570093-570123, 570125, 570126, 570128, 570131-570153, 570156-570203, 570205-570241, 570244-570248, 570250-570252, and 512684. Users should contact Beckman Coulter Inc. for further instructions on how to proceed with the recall.

The recalled product

Product
Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
227

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 (14)

  • Serial/Lot Numbers: 570005-570043
  • 570047-570049
  • 570051-570061
  • 570066-570071
  • 570073-570091
  • 570093-570123
  • 570125
  • 570126
  • 570128
  • 570131-570153
  • 570156-570203
  • 570205-570241
  • 570244-570248
  • 570250-570252 and 512684

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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