Recall record at a glance
| Official record | Z-1169-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Completed |
| Recalling firm | Beckman Coulter Inc. |
| Report date | Mar 28, 2018 |
| Recall initiation date | Jan 19, 2018 |
| Quantity | 98 units in the US |
| Location | Brea, CA, United States |
Official product description
AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255
Why the product was recalled
Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination.
Distribution information
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, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Other.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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