Z-2278-2015 Class II Terminated
FDA device recall Z-2278-2015 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: 100 each and 1,860 each (186 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
- 100 each and 1,860 each (186 pk/10)
Product Description
Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting
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: 15070 Cat no. R98 Lot number: 14193, 14232, 14251, 14272, and 14329 Cat no.: R72