HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires:… — Class II medical device recall Z-2192-2015
Terminated recall by Hardy Diagnostics, reported 2015-07-29. Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
| Recall number | Z-2192-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hardy Diagnostics, Santa Maria, CA, United States |
| Recall initiated | 2015-06-24 |
| Classified | 2015-07-22 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2015-08-28 |
| Quantity | 1,500 |
| Lot numbers | H15055 |
| Model numbers | G333, GA333 |
| Expiration dates | 2015-07-04 |
Product
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.
Reason for recall
Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2192-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.