Recalls / —
—#161060
Product
AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.
- FDA product code
- JQP — Calculator/Data Processing Module, For Clinical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- 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
Why it was recalled
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.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Beckman Coulter Inc.
- Address
- 250 S Kraemer Blvd, Brea, California 92821-6232
Distribution
- 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.
Timeline
- Recall initiated
- 2018-01-18
- Terminated
- 2023-09-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #161060. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.