Recall record at a glance
| Official record | Z-0341-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Leica Microsystems, Inc. |
| Report date | Dec 2, 2015 |
| Recall initiation date | Sep 3, 2015 |
| Quantity | U.S: 1 unit of CD10-270-CE-S & 66 units of CD10-270-CE. Foreign: 83 units of CD10-270-CE-S & 219 units of CD10-270-CE |
| Location | Buffalo Grove, IL, United States |
Official product description
Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
Why the product was recalled
These Lot numbers are not stable up to the expiry date on the product labeling.
Distribution information
Worldwide Distribution - US Nationwide, Australia, Austria, Brazil, Canada, China, Czech Republic, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Netherlands, Norway, Romania, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland and UK.
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: Letter.
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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