Recall Z-1151-2018
Beckman Coulter Inc. · initiated January 18, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.
Codes / lots: 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
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.
FDA-determined cause: Device Design
Action taken
A recall notification letter was sent to affected US consignees on 1/19/2018 notifying them of the issue. In addition, the recalling firm is instructing field service engineers to inspect the tip present sensor for misalignment at the next service visit.
Details
- Recall number
- Z-1151-2018
- Initiated
- January 18, 2018
- Terminated
- September 27, 2023
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Quantity
- 73 units in US
- Distribution
- 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…
- Recalling firm
- Beckman Coulter Inc., Brea, CA