Recall record at a glance
| Official record | Z-1229-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Report date | Mar 11, 2015 |
| Recall initiation date | Jan 27, 2015 |
| Quantity | 9778 kits |
| Location | East Walpole, MA, United States |
Official product description
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
Why the product was recalled
ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
Distribution information
Worldwide Distribution-US (nationwide), Austria, Bahrain, Belgium, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech, Republic, Denmark, Egypt, Estonia, France, Georgia, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Serbia, Slovakia, Spain, South America, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and 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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