Home / Recalls / Hardy Diagnostics / Z-2278-2015

Z-2278-2015 Class II Terminated

Recalled by Hardy Diagnostics — Santa Maria, CA

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

Other recalls by Hardy Diagnostics

  • Z-2041-2025 Class II — HardyCHROM CRE, selective and differential culture medium for antimicrobial susc (May 6, 2025)
  • Z-1835-2021 Class II — Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. (April 16, 2021)
  • Z-0919-2021 Class II — Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Man (December 21, 2020)
  • Z-0655-2021 Class II — Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/ (October 23, 2020)
  • Z-0441-2021 Class III — Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 (October 6, 2020)
  • Z-2298-2020 Class II — HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic (November 14, 2019)
  • Z-2146-2016 Class II — QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematica (May 24, 2016)
  • Z-1571-2016 Class II — Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detect (March 21, 2016)
  • Z-0470-2016 Class II — FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fast (November 18, 2015)
  • Z-2463-2015 Class II — HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Ty (July 9, 2015)