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Class 2 Device Recall RapidfFN for the TLiIQ(R) System |
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Date Initiated by Firm |
November 29, 2017 |
Create Date |
February 21, 2018 |
Recall Status1 |
Terminated 3 on August 22, 2018 |
Recall Number |
Z-0676-2018 |
Recall Event ID |
78832 |
PMA Number |
P920048 |
Product Classification |
Enzyme immunoassay, fetal fibronectin - Product Code LKV
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Product |
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200 |
Code Information |
K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082 |
Recalling Firm/ Manufacturer |
Hologic, Inc. 1240 Elko Dr Sunnyvale CA 94089-2212
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For Additional Information Contact |
Kathy Chester 408-745-0975 Ext. 128
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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.
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FDA Determined Cause 2 |
Mixed-up of materials/components |
Action |
Hologic initiated the recall on Wednesday, November 29, 2017. The method of notification was via overnight FedEx. |
Quantity in Commerce |
165 kits |
Distribution |
United States (US), Guam (GU), Japan (JP) |
Total Product Life Cycle |
TPLC Device Report
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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.
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PMA Database |
PMAs with Product Code = LKV and Original Applicant = HOLOGIC, INC.
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