Z-2864-2017Class II

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

Name: Z-2864-2017 Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument
Creator: Hologic, Inc
Published: 2017-06-27
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2017-06-27 / Terminated / root cause: software

FDA source

Hologic, Inc began a recall of Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument on 2017-06-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2864-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-27
Posted: 2018-10-11
Terminated: 2023-06-30
Recalling firm: Hologic, Inc.
Product: Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
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.
Root cause tag: software
FDA root 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2864-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2864-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-08-02

Product code JQW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)