Viral Transport Medium, 3ml, Ref: R99, Container type:… recallZ-0655-2021 · Hardy Diagnostics · initiated Oct 23, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hardy Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Material/Component Contamination
What the company is doing
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 [email protected], or by phone call at (800) 266-2222, option 2, Monday through Friday, 8:00 AM to 5:00 PM, Pacific Time.
Recall details
- Recall number
- Z-0655-2021
- Status
- Terminated
- Initiated by the company
- Oct 23, 2020
- Recalling firm
- Hardy Diagnostics
- Quantity
- 686,920 devices
- Product code
- JSM
- 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.
Product description
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 (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N/A R99Hardy Diagnostics · Culture Media, Non-Propagating Transport1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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