Z-2275-2015Class II
Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve
Hardy Diagnostics / initiated 2015-06-26 / Terminated
Hardy Diagnostics began a recall of Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2275-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Hardy Diagnostics
- Product
- Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.
- Product code
- JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- 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.
- FDA root cause
- No Marketing Application
- Action
- The firm initially called customers to inform them of the recall. The firm's phone script stated that they were discontinung the product and as part of the process were recalling anything that still might be within expiration date. The instructions provided via phone were to discard any remaining plates that are in stock in order for credit. The phone script stated that the firm was going to be sending something in writing. On 06/25-29/15 the firm sent out notification letters to customers to inform them that they were discontuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the endlosed form stating their compliance with the above action. The notification states if the laboratory was unable to be reached via telephone and would like a credit to contact the Customer Service Department at 800-266-2222, option 1. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at [email protected]. Follow-up calls will be made to customers who do not respond.
- Quantity in commerce
- 650 (65 pk/10)
- Distribution
- U.S. Nationwide Distribution and the country of: Canada
- Product codes and lots
- Lot number: 15092, 15101, 15113 Cat no. G259
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2273-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2274-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2275-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2276-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2277-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2278-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2279-2015 | Class II | Terminated | Voluntary: Firm initiated |
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