Home / Recalls / Hardy Diagnostics / Z-2277-2015

Z-2277-2015 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 (10 pk/10)

Product Description

Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).

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: 15105 Cat no. G107

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  • 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)
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  • 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)