—#172385

Product

Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

FDA product code: JSG — Culture Media, Non-Selective And Non-Differential
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Material Number: R08858; Lot Number (Labeled Expiration Date): 343868 (02/14/2019), 369544 (04/08/2019), 387018 (05/09/2019).

Why it was recalled

Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Thermo Fisher Scientific/ Remel notified consignees on about 04/17/2019 via " URGENT MEDICAL DEVICE FIELD ACTION RECALL" letter. Instructions included to locate all affected in inventory, destroy any affected product identified, contact Customer Services or local distributor to arrange for replacements, notify all customers if product was further distributed, and complete and return the Field Action Response form. Customers were also instructed that the requirement for review of reported test results using product beyond the updated expiry date should be determined by the appropriate technical expert at each customer location. Thermo Fisher Scientific/Remel expanded the recall and notified consignees on about 05/08/2019 via "URGENT MEDICAL DEVICE FIELD ACTION RECALL AMENDED NOTICE: ADDITIONAL IMPACTED LOTS" letter. The letter contained the same instructions as the initial letter, but the updated letter provided the additional impacted lots and requested that consignees respond again confirming receipt and understanding of the expansion. Questions or concerns can be directed to Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Worldwide Distribution -US Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico. International distribution to Canada.

Timeline

Recall initiated: 2019-04-17
Terminated: 2020-07-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172385. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.