CLASS II Device recall · Reported 29 Jul 2015 · FDA Enforcement Report
HardyCHROM VRE Agar-RSR recalled by Hardy Diagnostics
Hardy Diagnostics is recalling HardyCHROM VRE Agar-RSR, distributed in South Carolina. The recall was initiated on 24 Jun 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-2192-2015
- FDA event ID
- 71577
- Recalling firm
- Hardy Diagnostics, Santa Maria, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jun 2015
- FDA classified
- 22 Jul 2015
- Reported
- 29 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 24 Jun 2015 | Recall initiated by company | |
| 22 Jul 2015 | Classified by FDA | +28 days |
| 29 Jul 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 VRE Agar due to lack of 510(k) clearance.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Distributed to one U.S. customer in SC.
Questions about this recall
Why was it recalled?
Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
Which lots are affected?
Cat No.: G333 Lot No.: H15055
Where was it sold?
Distributed to one U.S. customer in SC.
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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