Z-2276-2015 Class II Terminated
FDA device recall Z-2276-2015 was initiated by Hardy Diagnostics on June 26, 2015 and is designated Class II. 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, Gentam… The recall status is terminated (terminated September 11, 2015). Affected quantity: 5,940 (5940 pk/10).
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2015
- Initiation Date
- June 26, 2015
- Termination Date
- September 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,940 (5940 pk/10)
Product Description
Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.
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.
Distribution Pattern
U.S. Nationwide Distribution and the country of: Canada
Code Information
Lot number: 15075. 15096, 15107, 15121, 15134, and 15154 Cat no. G103