Device product
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Z-0585-2026
Product summary
- Firm
- Remel, Inc
- Event
- Event 97967
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,000 US, 280 ROW
- Official record key
device-enforcement:Z-0585-2026
Official wording
Reason: Products may contain contamination, which may result in a darker or brown media color.
Code information: 1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993 2. UDI-DI 848838091353, lot 317287
Distribution pattern: Worldwide - US Nationwide distribution in the states of AK, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, NE, NY, OH, OK, PA, RI, SD, TN, VA, WA, WI and the countries of Brazil, Canada, China, Cyprus, Finland, Great Britain, Ireland, Moldova, Norway, Singapore.
Derived failure modes
-
Unknown
Products may contain contamination, which may result in a darker or brown media color.