Home / Recalls / Hardy Diagnostics / Z-2298-2020

Z-2298-2020 Class II Terminated

Recalled by Hardy Diagnostics — Santa Maria, CA

Recall Details

Product Type
Devices
Report Date
June 17, 2020
Initiation Date
November 14, 2019
Termination Date
April 28, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,580 ea (358 kits, pack of 10 in each)

Product Description

HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required for susceptibility or typing. Container Type: 15 x 100mm monoplate Packaged: 10 plates/sleeve STORAGE: 2-8 degree C on receipt, LIGHT SENSITIVE IVD UDI: (01)08165760201400 (10)447694 (17)191206

Reason for Recall

False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.

Distribution Pattern

U.S. Distribution in the states of WI, CA, WA, IA, MT, UT, AZ, WY, KS, MO, OR, TX, VI, including PR and Guam. OUS: British Virgin Islands, Kenya,

Code Information

Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140

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  • 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-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)