Recall record at a glance
| Official record | Z-2742-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Report date | Sep 14, 2016 |
| Recall initiation date | Aug 9, 2016 |
| Location | East Walpole, MA, United States |
Official product description
ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Why the product was recalled
Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
Distribution information
Nationwide Albania Algeria Angola Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France Georgia Germany Great Britain Greece Hungary Iceland Iraq Italy Jordan Kazakhstan Latvia Lithuania Luxembourg Macedonia Malta Netherlands Norway Pakistan Poland Portugal Qatar Romania Russian Fed. Senegal Serbia Slovakia Slovenia Spain Sweden Switzerland Tunisia Turkey Unit.Arab Emir. Uzbekistan Vatican
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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