Z-0676-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2018
- Initiation Date
- November 29, 2017
- Termination Date
- August 22, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165 kits
Product Description
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Reason for Recall
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.
Distribution Pattern
United States (US), Guam (GU), Japan (JP)
Code Information
K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082