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Open, Classified

Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.

FDA Recall Z-0449-2021 · Posted None

Recalling FirmThomas Scientific
Recall StatusOpen, Classified
Product CodeLIO
Date Initiated2020-07-14
Product Quantity115,800 cs (100 vials/cs)

Reason for Recall

The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.

Firm 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.

Root Cause

No Marketing Application

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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