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U.S. Department of Health and Human Services

Class 2 Device Recall CVM Transport Media

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  Class 2 Device Recall CVM Transport Media see related information
Date Initiated by Firm October 23, 2020
Create Date December 21, 2020
Recall Status1 Terminated 3 on September 20, 2022
Recall Number Z-0655-2021
Recall Event ID 86853
Product Classification Culture media, non-propagating transport - Product Code JSM
Product Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD,

CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
Code Information UDI: (00)819398023818 Lot Number /Expiration Date  129507P /10/28/2020, 129735P /11/11/2020, 129320P /10/14/2020, 129932P /11/23/2020, 130049P /11/29/2020, 460929P /11/4/2020, 463439P /12/14/2020, 463986P /12/22/2020, 459930P /10/17/2020, 460805P /11/2/2020, 462411P /11/30/2020, 459717P /10/8/2020, 463483P /12/15/2020, 462121P /11/26/2020, 460391P /10/25/2020, 463782P /12/20/2020, 461645P /11/17/2020, 461643P /11/17/2020, 461289P /11/11/2020, 461381P /11/12/2020, 460561P /10/28/2020, 459718P /10/11/2020, 461994P /11/24/2020, 462076P /11/25/2020, 466688 /2/1/2021, 459774P /10/12/2020, 460618P /10/29/2020, 461262P /11/11/2020, 461378P /11/12/2020, 462375P /11/30/2020, 461995P /11/24/2020, 460997P /11/7/2020, 464517 /12/29/2020, 460802P /11/2/2020, 459830P /10/13/2020, 460565P /10/28/2020, 460290P /10/24/2020, 461013P /11/5/2020, 464529 /12/30/2020, 460621P /10/29/2020, 459345P /10/4/2020, 460939P /11/4/2020, 458991P /9/27/2020, 460506P /10/27/2020, 460954P /11/5/2020, 461362P /11/12/2020, 461832P /11/22/2020, 462511P /12/1/2020, 460433P /10/26/2020  
Recalling Firm/
Manufacturer		 Hardy Diagnostics
1430 W McCoy Ln
Santa Maria CA 93455-1005
For Additional Information Contact Hardy Diagnostics Technical Service
800-266-2222 Ext. 2
Manufacturer Reason
for Recall		 There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing.
FDA Determined
Cause 2		 Material/Component Contamination
Action On October 23, 2020, Hardy Diagnostics issued a "Urgent: Recall Notification" to affected consignees via US Mail, E-Mail, and/or Facsimile. In addition to informing consignees about the recalled device, the firm requested that consignees take the following actions: 1. Please retain this letter or post the letter where the product is stored to ensure the users are aware of this defect. 2. Notify any and all employees who may use the product. 3. If the product was further distributed, notify the consignees the product was distributed to. 4. Please complete the "Manufactured Item Product Recall/Withdrawal Customer Inventory Form" and return within (5) working days. Fax replies to: 805-361-5050. 5. Any Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online (www.fda.gov/medwatch/report.htm), by regular mail or by fax. 6. If you have question, please contact Technical Services by email, at TechnicalServices@HardyDiagnostics.com, or by phone call at (800) 266-2222, option 2, Monday through Friday, 8:00 AM to 5:00 PM, Pacific Time.
Quantity in Commerce 686,920 devices
Distribution US Nationwide Distribution: CA, NC, AK, NY, OH, IL, NC, WI, SD, FL, DE, MI, MA, MD, GA, , TX, PA, IA, WV, ID, UT, KS, OR, CT, NY, WA, VA, TN, HI, AL, KY, MN, PR, MO, WI, AZ, SC, LA, AR, IN, NE, MS, NH, and OK.
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.
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