Z-2864-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2017
- Initiation Date
- June 27, 2017
- Termination Date
- June 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 164 units
Product Description
Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
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 Pattern
Worldwide distribution. US Nationwide and countries: BE, CA, CH, ES, FR, GB, IE, IT, JP, LU, NL, SE, SK, and TR.
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