Device product
Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Z-1380-2019
Product summary
- Firm
- Remel Inc
- Event
- Event 82677
- Status
- Terminated
- Classification
- Class II
- Quantity
- 242 units
- Official record key
device-enforcement:Z-1380-2019
Official wording
Reason: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Code information: Lot Number (Expiration Date): 309152 (10/10/2018), 337708 (12/03/2018), 353574 (01/02/2019), 378524 (02/20/2019).
Distribution pattern: Worldwide Distribution -US Nationwide distribution to AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, VA, VT, WA, WI, WV, WY, Puerto Rico. International distribution to Singapore
Derived failure modes
-
Unknown
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.