CLASS II Device recall · Reported 22 Apr 2015 · FDA Enforcement Report
Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM recalled
Hardy Diagnostics is recalling Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM, distributed in Arizona, California, Iowa, Puerto Rico, Texas, Washington. The recall was initiated on 4 Mar 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-1444-2015
- FDA event ID
- 70767
- Recalling firm
- Hardy Diagnostics, Santa Maria, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Mar 2015
- FDA classified
- 14 Apr 2015
- Reported
- 22 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Bacterial Contamination
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Mar 2015 | Recall initiated by company | |
| 14 Apr 2015 | Classified by FDA | +41 days |
| 22 Apr 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot.
Product as listed by the FDA
Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.
Where it was distributed
Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.
Questions about this recall
Why was it recalled?
The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot.
Which lots are affected?
Lot no. 15037, Expires: 00-00-2000
Where was it sold?
Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.
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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