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U.S. Department of Health and Human Services

Class 2 Device Recall G307HardyCHROM MRSA

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  Class 2 Device Recall G307HardyCHROM MRSA see related information
Date Initiated by Firm November 14, 2019
Date Posted June 09, 2020
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-2298-2020
Recall Event ID 85412
510(K)Number K102922  
Product Classification Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
Product 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
Code Information Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140
Recalling Firm/
Manufacturer		 Hardy Diagnostics
1430 W McCoy Ln
Santa Maria CA 93455-1005
For Additional Information Contact Andre Hsiung
805-346-2766
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 11/14/2019, the firm sent a notification of recall letter to customers, informing them of the performance issue of the device lot of the breakthrough on firm's differential chromogenic medium. The customers were advised to discard the remaining stock, and notify the Technical Services Department. If the customer would like replacement or credit, contact Technical Services Department or via e-mail at TechService@HardyDiagnostics.com, or 800-266-2222 option 2 or ext. 5658.
Quantity in Commerce 3,580 ea (358 kits, pack of 10 in each)
Distribution 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,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JSO and Original Applicant = HARDY DIAGNOSTICS
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