Device product
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
Z-2278-2015
Product summary
- Event
- Event 71602
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 each and 1,860 each (186 pk/10)
- Official record key
device-enforcement:Z-2278-2015
Official wording
Reason: 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.
Code information: Lot number: 15070 Cat no. R98 Lot number: 14193, 14232, 14251, 14272, and 14329 Cat no.: R72
Distribution pattern: U.S. Nationwide Distribution and the country of: Canada
Derived failure modes
-
Unknown
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.