Recall record at a glance
| Official record | Z-0737-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Diagnostica Stago, Inc. |
| Report date | Jan 1, 2020 |
| Recall initiation date | Nov 18, 2019 |
| Quantity | 5,498 |
| Location | Parsippany, NJ, United States |
Official product description
STA UNICALIBRATOR (ref. 00675)
Why the product was recalled
A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
Distribution information
US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK
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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