Hardy Diagnostics: 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

Recall number

Z-0655-2021

Recalling firm

Hardy Diagnostics

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

Status

Terminated

Initiated

2020-10-23

Posted

not on file

Terminated

2022-09-20

Reason

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.

Root cause

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

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

JSM

Firm FEI

2022807

Firm city

Santa Maria

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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