CLASS II Device recall · Reported 5 Aug 2015 · FDA Enforcement Report
BHI with Cipro, 1ug/ml container type recalled by Hardy Diagnostics
Hardy Diagnostics is recalling Hardy Diagnostics BHI with Cipro, 1ug/ml container type: 16x100mm tube packaged: 20, distributed nationwide in the US. The recall was initiated on 26 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-2274-2015
- FDA event ID
- 71602
- Recalling firm
- Hardy Diagnostics, Santa Maria, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jun 2015
- FDA classified
- 29 Jul 2015
- Reported
- 5 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Jun 2015 | Recall initiated by company | |
| 29 Jul 2015 | Classified by FDA | +33 days |
| 5 Aug 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 MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth 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
Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.
Where it was distributed
U.S. Nationwide Distribution and the country of: Canada
Questions about this recall
Is BHI with Cipro, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box recalled?
Yes. Hardy Diagnostics recalled BHI with Cipro, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box on 26 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-2274-2015.
Why was it recalled?
Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.
Which lots are affected?
Lot number: 15055, 15083, and 15091
Where was it sold?
U.S. Nationwide Distribution and the country of: Canada
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 21 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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