Recall record at a glance
| Official record | Z-1179-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Ortho-Clinical Diagnostics |
| Report date | Feb 15, 2017 |
| Recall initiation date | Dec 8, 2016 |
| Quantity | 37,571 packs/90 slides totalling 3,381,390 slides |
| Location | Rochester, NY, United States |
Official product description
VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
Why the product was recalled
There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
Distribution information
Worldwide distribution - Nationwide U.S.A; International - Bermuda, Australia, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
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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