Beckman Coulter Inc.: Medical Device Recall in 2018 - (Recall #: Z-0308-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: November 6, 2017

Date Posted: January 10, 2018

Recall Number: Z-0308-2018

Event ID: 78613

Reason for Recall:

Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.

Status: Terminated

Product Quantity: 227 units

Code Information:

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 Pattern:

Worldwide Distribution -- US, 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.

Voluntary or Mandated:

Voluntary: Firm initiated