Z-0449-2021Class II

Wuxi Nest, model numbers 202115, 202117, 202017, 202018 -

Name: Z-0449-2021 Wuxi Nest, model numbers 202115, 202117, 202017, 202018 -
Creator: Thomas Scientific
Published: 2020-07-14
License: https://open.fda.gov/license/

Thomas Scientific / initiated 2020-07-14 / Open, Classified / root cause: manufacturing process

FDA source

Thomas Scientific began a recall of Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection on 2020-07-14. FDA classified it as Class II and gives the reason as "The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0449-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-07-14
Posted: 2020-11-13
Recalling firm: Thomas Scientific
Product: Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Product code: LIO Device, Specimen Collection
Reason for recall: The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.
Root cause tag: manufacturing process
FDA root cause: No Marketing Application
Action: On 8/31/20, the firm provided FEMA with the recall letter, which was distributed to all affected users. Users were informed that product manufactured and distributed prior to Enforcement Discretion Approval was to be removed. The firm offered to replace any returned product. To report and receive replacement, customers should complete the included VTM Product Replacement Form and return it to [email protected]. Thomas Scientific will replace any product that has been returned. Please contact [email protected] for any requests for field support.
Quantity in commerce: 115,800 cs (100 vials/cs)
Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Product codes and lots: Lots 060620MB1 061420MB2 062120MB1 062220MB2 060620MB2 052220MB1 051820D01 060120D01 061520MA1 062220D02 061720MB1 052720D02 061920E01 052120E01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0449-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0449-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-25	2020-11-13

Product code LIO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)