Recall record at a glance
| Official record | Z-1363-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Report date | Mar 4, 2020 |
| Recall initiation date | Dec 20, 2019 |
| Quantity | 3224 |
| Location | Tarrytown, NY, United States |
Official product description
ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct.
Why the product was recalled
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
Distribution information
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CT, FL, GA, IA, KS, MD, MI, NJ, NM, NY, OH, OK, PA, TN, TX, WA.
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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