Recall record at a glance
| Official record | Z-1685-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Diamedix Corporation |
| Report date | May 25, 2016 |
| Recall initiation date | Oct 20, 2014 |
| Quantity | 697 kits |
| Location | Miami Lakes, FL, United States |
Official product description
Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
Why the product was recalled
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Distribution information
Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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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