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U.S. Department of Health and Human Services

Class 2 Device Recall RapidfFN for the TLiIQ(R) System

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 Class 2 Device Recall RapidfFN for the TLiIQ(R) Systemsee related information
Date Initiated by FirmNovember 29, 2017
Create DateFebruary 21, 2018
Recall Status1 Terminated 3 on August 22, 2018
Recall NumberZ-0677-2018
Recall Event ID 78832
PMA NumberP920048 
Product Classification Enzyme immunoassay, fetal fibronectin - Product Code LKV
ProductRapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
Code Information E7058
Recalling Firm/
Manufacturer		 Hologic, Inc.
1240 Elko Dr
Sunnyvale CA 94089-2212
For Additional Information ContactKathy Chester
408-745-0975 Ext. 128
Manufacturer 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.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionHologic initiated the recall on Wednesday, November 29, 2017. The method of notification was via overnight FedEx.
DistributionUnited States (US), Guam (GU), Japan (JP)
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = LKV
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