FDA Device recall Z-1151-2018
AutoMate 2550 "High Speed" Catalog Number ODL25255
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of AutoMate 2550 "High Speed" Catalog Number ODL25255 by Beckman Coulter, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1151-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-18 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.
Reason
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.
Identifiers
| code_info | All units in the AutoMate 2500 Family are affected; Serial Numbers - 1107, 4048, 4055, 4025, 4052, 4079, 4091, 4…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1151-2018%22
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