medical MODERATE Updated 2017-08-09

Hologic, Inc recalls Tomcat Instrument, REF ASY-07379, Hologic Incorporated, auto

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Recalled Product

Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall