Recall record at a glance
| Official record | Z-1743-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Technidata S.A. |
| Report date | Jul 24, 2013 |
| Recall initiation date | Jun 20, 2013 |
| Quantity | 1 site |
| Location | Montbonnot St Martin, N/A, France |
Official product description
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
Why the product was recalled
A recall was initiated by Technidata because use of symbols (less than or equal to or greater than or equal to or any other symbol) in Microsoft Word reports when using electronic transmissions of results by of HPRIM (including HPRIM Medecin via Kermit) or HL7 must be absolutely prohibited. Such symbols are not supported by the Microsoft Word interface used by the Histology/Cytology software and
Distribution information
US Distribution CA only.
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement 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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.