Beckman Coulter Inc.: Medical Device Recall in 2018 - (Recall #: Z-1151-2018)

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:

AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.

Product Classification:

Class II

Date Initiated: January 18, 2018

Date Posted: March 28, 2018

Recall Number: Z-1151-2018

Event ID: 78999

Reason for Recall:

A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip error, resulting in pipetting patient samples without pipette tips.

Status: Terminated

Product Quantity: 73 units in US

Code Information:

All units in the AutoMate 2500 Family are affected; Serial Numbers - 1107, 4048, 4055, 4025, 4052, 4079, 4091, 4076, 4072, 4073, 4074, 4111, 4097, 1054, 1055, 1048, 1049, 1147, ODL25125-1342, ODL25125-1354, 1251, ODL25255-4530, ODL25255-4531, 4126, 4127, 4169, 4171, 4341, 4324, ODL25255-4536, ODL25255-4535, ODL25255-4397, 4141, 4143, 4144, 4146, ODL25255-4606, 4148, ODL25255-4577, ODL25255-4605, 4302, 4304, 4352, ODL25255-4352, 4330, ODL25255-4419, ODL25255-4534, ODL25255-4416, ODL25255-4401, 4168, 4107, 4255, 4257, 4252, 4256, 4254, 4253, 4236, ODL25255-4437, ODL25255-4443, ODL25255-4444, ODL25255-4438, 4294, 4293, ODL25255-4556, ODL25255-4382, ODL25255-4378, ODL25255-4377, ODL25255-4379, ODL25255-4380, ODL25255-4381, ODL25255-4420, ODL25255-4421

Distribution Pattern:

Worldwide distribution. US nationwide, Algeria, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Macao, Mayotte, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated