HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13… — Class II medical device recall Z-2463-2015
Terminated recall by Hardy Diagnostics, reported 2015-09-02, distributed in IL, MD, NJ, NY, OH, PA, VA. Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methic
| Recall number | Z-2463-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hardy Diagnostics, Santa Maria, CA, United States |
| Recall initiated | 2015-07-09 |
| Classified | 2015-08-26 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2015-11-10 |
| Distributed | IL, MD, NJ, NY, OH, PA, VA |
| Pathogens | staphylococcus |
| Lot numbers | H15155 |
| Model numbers | G307 |
| Expiration dates | 2015-08-13 |
Product
HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
Reason for recall
Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.
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-2463-2015. 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.