CLASS II Device recall · Reported 2 Sep 2015 · FDA Enforcement Report
HardyCHROM MRSA recalled by Hardy Diagnostics
Hardy Diagnostics is recalling HardyCHROM MRSA, distributed in 7 states. The recall was initiated on 9 Jul 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2463-2015
- FDA event ID
- 71804
- Recalling firm
- Hardy Diagnostics, Santa Maria, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jul 2015
- FDA classified
- 26 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Bacterial Contamination
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Jul 2015 | Recall initiated by company | |
| 26 Aug 2015 | Classified by FDA | +48 days |
| 2 Sep 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Cat no. G307 Lot no. H15155
Where was it sold?
Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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