Recall record at a glance
| Official record | Z-0878-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Report date | Jan 11, 2023 |
| Recall initiation date | Nov 17, 2022 |
| Quantity | 4,158 units |
| Location | Rochester, NY, United States |
Official product description
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
Why the product was recalled
Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results
Distribution information
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Bermuda HM12, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
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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