FDA-Device2018-02-28Class II
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Hologic, Inc.
Hazard
Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.
Sold states
United States (US), Guam (GU), Japan (JP)
Affected count
165 kits
Manufactured in
1240 Elko Dr, N/A, Sunnyvale, CA, United States
Products
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0676-2018Don't want to check this manually?
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