Z-2990-2020Class II

Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000

Name: Z-2990-2020 Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Creator: Hologic, Inc
Published: 2020-08-04
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2020-08-04 / Terminated

FDA source

Hologic, Inc began a recall of Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000 on 2020-08-04. FDA classified it as Class II and gives the reason as "Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2990-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-04
Posted: 2020-09-21
Terminated: 2024-12-23
Recalling firm: Hologic, Inc.
Product: Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Product code: NSU Instrumentation For Clinical Multiplex Test Systems
Reason for recall: Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.
FDA root cause: Under Investigation by firm
Action: On 08/04/20, Medical Device Recall Notifications were mailed to Laboratory Managers, Site Administrators, and Operators. Customers were asked to do the following: 1. Discontinue use. 2. Immediately check inventory and segregate affected devices. 3. Complete the customer response form. Document the remaining inventory. Destroy the segregated inventory. Return the customer response form even if there is no affected inventory present. 4. There is no other specific actions to the assays. 5. Recalling firm will ship replacement product based on the customer response form information.
Quantity in commerce: 607
Distribution: U.S. :ID, SC, VT, CA, IL, UT, NJ, MA, TX, AL, CO, FL, ME, NY, VA, WA, WI, OR, DC, GA, NC, HI, CT, OK, TN, O.U.S.: CA, SE, GB, DE, DO, IT, ES, NO, BE, NL, FR, DK, AT
Product codes and lots: Box/ Tray lots: 271436/ 618539, 271438/ 620899, 272089/ 620899, 272959/ 621837, 272970/ 621256, 272971/ 621837, 274670/ 625351

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2990-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2990-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-21

Product code NSU

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)