Device product
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Z-1876-2025
Product summary
- Event
- Event 96784
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,587 units
- Official record key
device-enforcement:Z-1876-2025
Official wording
Reason: Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
Code information: Catalog number: 8097990; GTIN#: 10758750004355; Coating Number: 1291; Lot No. 3788-1291-0019, 3788-1291-0052, 3788-1291-0078, 3788-1291-0079, 3788-1291-0080, 3788-1291-9975.
Distribution pattern: Worldwide - US Nationwide distribution in the states of AR, AZ, CO, FL, GA, ID, IL, IN, KS, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WI, WV & WY and the countries of Canada, Chile, Colombia, France, India, Italy, Mexico & Singapore.
Derived failure modes
-
Unknown
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.