Z-0677-2018 Class II Terminated
FDA device recall Z-0677-2018 was initiated by Hologic, Inc. on November 29, 2017 and is designated Class II. 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. The recall status is terminated (terminated August 22, 2018). Affected quantity: N/A.
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
- N/A
Product Description
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
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
E7058