Recall Z-2864-2017 ยท JQW Station, Pipetting And Diluting, For Clinical Use
Hologic, Inc
Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
| Date | Jun 27, 2017 |
| Status | Terminated |
| Reason | 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 | 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 pri |
| Quantity | 164 units |
| Distribution | Worldwide distribution. US Nationwide and countries: BE, CA, CH, ES, FR, GB, IE, IT, JP, LU, NL, SE, SK, and TR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.