Reported Aug 9, 2017 · Terminated

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

Hologic, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hologic, Inc · 10210 Genetic Center Dr · San Diego, CA · 92121-4362

Is this the product you have?

  • Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
Lot codes and dates
  • 162 of 162 codes

    • 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
Amount recalled
164 units

Where it was sold

  • Nationwide
  • CA

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 30, 2023 · Data as of Sep 19, 6:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.