Recall record at a glance
| Official record | Z-2192-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Hardy Diagnostics |
| Report date | Jul 29, 2015 |
| Recall initiation date | Jun 24, 2015 |
| Quantity | 1,500 |
| Location | Santa Maria, CA, United States |
Official product description
HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.
Why the product was recalled
Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
Distribution information
Distributed to one U.S. customer in SC.
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: Telephone.
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.