Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
- Company
- Hologic, Inc
- Recall Initiated
- June 27, 2017
- Terminated
- June 30, 2023
- Recall Number
- Z-2864-2017
- Quantity
- 164 units
- Firm Location
- San Diego, CA
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.
Distribution
Worldwide distribution. US Nationwide and countries: BE, CA, CH, ES, FR, GB, IE, IT, JP, LU, NL, SE, SK, and TR.
Lot / Code Info
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
Root Cause
Software design
Action Taken
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.