CLASS II Device recall · Reported 30 Sep 2020 · FDA Enforcement Report

Panther Fusion Tube Tray, Part: FAB recalled by Hologic

Hologic is recalling Panther Fusion Tube Tray, Part: FAB-15004, distributed in 26 states. The recall was initiated on 4 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBox/ Tray lots: 271436/ 618539, 271438/ 620899, 272089/ 620899, 272959/ 621837, 272970/ 621256, 272971/ 621837, 274670/ 625351

Quantity recalled607

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2990-2020
FDA event ID: 86248
Recalling firm: Hologic, San Diego, CA
Classification: Class II
Status: Terminated
Recall initiated: 4 Aug 2020
FDA classified: 21 Sep 2020
Reported: 30 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

4 Aug 2020	Recall initiated by company
21 Sep 2020	Classified by FDA	+48 days
30 Sep 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

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

Alabama California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Idaho Illinois Massachusetts Maine North Carolina New Jersey New York Oklahoma Oregon South Carolina Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

Box/ Tray lots: 271436/ 618539, 271438/ 620899, 272089/ 620899, 272959/ 621837, 272970/ 621256, 272971/ 621837, 274670/ 625351

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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