Abbott Laboratories, Inc: Medical Device Recall in 2021 - (Recall #: Z-2276-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.

Product Classification:

Class II

Date Initiated: July 12, 2021

Date Posted: August 18, 2021

Recall Number: Z-2276-2021

Event ID: 88324

Reason for Recall:

A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.

Status: Ongoing

Product Quantity: 260 systems

Code Information:

Model Number: LN 06P16-01 Serial numbers AS1001 through AS1330

Distribution Pattern:

Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Mexico, Netherlands, Pakistan, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Tanzania, United Arab Emirates, United Kingdom, Ukraine and Zimbabwe.

Voluntary or Mandated:

Voluntary: Firm initiated