Recall record at a glance
| Official record | Z-2184-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Cellavision AB |
| Report date | Jun 20, 2018 |
| Recall initiation date | Dec 4, 2017 |
| Quantity | Instruments: 224 Software: 99 (US) |
| Location | Lund, N/A, Sweden |
Official product description
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
Why the product was recalled
A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.
Distribution information
US Nationwide in the states of FL, IL, NY, and NC
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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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