Recall Z-0677-2018— Hologic, Inc.
Class II · Terminated
Class II FDA medical device recall by Hologic, Inc., initiated 2017-11-29, terminated 2018-08-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q. Reason: 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..
- Recalling firm
- Hologic, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-29
- Terminated
- 2018-08-22
- Firm location
- Sunnyvale, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.