Class 2 Device Recall Tomcat Instrument

• Date Initiated by Firm: June 27, 2017
• Create Date: October 11, 2018
• Recall Status: Terminated on June 30, 2023
• Recall Number: Z-2864-2017
• Recall Event ID: 77697
• Product Classification: Station, pipetting and diluting, for clinical use - Product Code JQW
• Product: Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
• Code Information: TC00000050,TC00000058,TC00000059,TC00000060,TC00000061,TC00000062,TC00000063,TC00000064,TC00000065,TC00000067,TC00000068,TC00000069,TC00000070,TC00000071,TC00000072,TC00000073,TC00000074,TC00000075,TC00000076,TC00000077,TC00000078,TC00000079TC00000080,TC00000081,TC00000082,TC00000083,TC00000085,TC00000086,TC00000087,TC00000088,TC00000089,TC00000090,TC00000091,TC00000092,TC00000093,TC00000094,TC00000096,TC00000097,TC00000098,TC00000099,TC00000100,TC00000101,TC00000102,TC00000103,TC00000104,TC00000105,TC00000106,TC00000107,TC00000108,TC00000109TC00000110,TC00000111,TC00000112,TC00000113,TC00000114,TC00000115,TC00000116,TC00000117,TC00000118,TC00000119,TC00000120,TC00000121,TC00000123,TC00000124,TC00000125,TC00000126,TC00000127,TC00000128,TC00000129,TC00000130,TC00000131,TC00000132,TC00000133,TC00000134,TC00000136,TC00000137,TC00000138,TC00000139,TC00000140,TC00000141,TC00000142,TC00000143,TC00000144,TC00000145,TC00000146,TC00000147,TC00000148,TC00000149,TC00000150,TC00000151,TC00000152,TC00000153,TC00000154,TC00000155,TC00000156,TC00000157,TC00000158,TC00000159,TC00000160,TC00000161,TC00000162,TC00000163,TC00000164,TC00000165,TC00000166,TC00000167,TC00000168,TC00000170,TC00000171,TC00000172,TC00000173,TC00000174,TC00000175,TC00000177,TC00000178,TC00000179,TC00000181,TC00000182,TC00000183,TC00000184,TC00000185,TC00000187,TC00000188,TC00000189,TC00000190,TC00000191,TC00000192,TC00000193,TC00000195,TC00000197,TC00000198,TC00000199,TC00000200,TC00000201,TC00000202,TC00000203,TC00000204,TC00000206,TC00000207,TC00000208,TC00000209,TC00000210,TC00000211,TC00000212,TC00000213,TC00000214,TC00000215,TC00000227,TC00000236,TC00000242,TC00000249,TC00000254,TC00000263,TC00000264,TC00000266,TC00000270,TC00000273,TC00000274,TC00000280,TC00000283,TC00000284,TC00000285,TC00000289,TC00000291
• Recalling Firm/ Manufacturer: Hologic, Inc; 10210 Genetic Center Dr; San Diego CA 92121-4362
• For Additional Information Contact: Kathy Chester; 858-410-8178
• Manufacturer Reason for Recall: A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results.
• FDA Determined Cause: Software design
• Action: Hologic initiated the recall on Tuesday, June 27, 2017. The method of notification with either: ¿ A letter will be provided at a face-to-face meeting with a Hologic representative. ¿ Customers will be contacted by phone and electronically sent the letters. The letters will be delivered in one of the following ways: ¿ A Hologic representative will hand-deliver the recall letter to the laboratory management. Or ¿ Customers will be contacted by phone and electronically sent the letters. The letter states the problem and that a software fix is available. Those with who have the problem will have priority repair.
• Quantity in Commerce: 164 units
• Distribution: Worldwide distribution. US Nationwide and countries: BE, CA, CH, ES, FR, GB, IE, IT, JP, LU, NL, SE, SK, and TR.
• Total Product Life Cycle: TPLC 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.