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Recall Observatory FDA recall evidence

Device product

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

Z-0676-2018

November 29, 2017

Class II

Product summary

Firm
Hologic, Inc.
Event
Event 78832
Status
Terminated
Classification
Class II
Quantity
165 kits
Official record key
device-enforcement:Z-0676-2018

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: K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082

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.