Device product

Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q

Z-0677-2018

November 29, 2017

Class II

Product summary

Firm: Hologic, Inc.
Event: Event 78832
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: device-enforcement:Z-0677-2018

Official wording

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.

Code information: E7058

Distribution pattern: United States (US), Guam (GU), Japan (JP)

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.