Home / Recalls / Hardy Diagnostics / Z-0919-2021

Z-0919-2021 Class II Terminated

Recalled by Hardy Diagnostics — Santa Maria, CA

Recall Details

Product Type
Devices
Report Date
February 3, 2021
Initiation Date
December 21, 2020
Termination Date
September 28, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
820 units (82 PK10)

Product Description

Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml

Reason for Recall

Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.

Distribution Pattern

U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None

Code Information

Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698

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  • 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)
  • Z-2278-2015 Class II — Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube p (June 26, 2015)