Z-1369-2021Class II

Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays -

Name: Z-1369-2021 Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays -
Creator: Hologic, Inc
Published: 2021-02-26
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2021-02-26 / Open, Classified / root cause: manufacturing process

FDA source

Hologic, Inc began a recall of Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used... on 2021-02-26. FDA classified it as Class II and gives the reason as "There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1369-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-02-26
Posted: 2021-04-07
Recalling firm: Hologic, Inc.
Product: Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.
Product code: NSU Instrumentation For Clinical Multiplex Test Systems
Reason for recall: There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On February 26, 2021, Hologic, issued "Urgent: Medical Device Recall Notification" to affected consignees via FedEx. In addition, to informing consignees about the recall, they asked customers to take the following actions: Laboratory Action: A. Please immediately discontinue use of the Panther Fusion Tube Tray lots listed in Table 1. B. Please immediately check your inventory and segregate the Panther Fusion Tube Tray lots listed in Table 1. C. The number of tube tray boxes shipped to your site is identified on the accompanying document. (GBS customers will receive a blank form and will need to fill in lot number and quantity.) - Please fill out the documents completely, including the number of boxes of the specified lots remaining in inventory (whether unopened or partial boxes). - After completing the document, destroy the segregated inventory. - Sign the document to signify compliance and return it as instructed on the document. - Please do this even if you do not have any of the affected trays remaining in your inventory. D. Hologic will ship replacement product to your site based on the number of boxes of the specified lots you list as remaining in your inventory on the document you return. E. Please ensure that appropriate laboratory personnel are notified of the information herein. F. If you have any questions or concerns about this notification or about the replacement product, please contact Hologic Technical Support at 1888-484-474- or [email protected]
Quantity in commerce: 1355 kits
Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, IN, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, TX, UT, VA, VT, WA, WI, WV and the countries of Austria (AT), Belgium (BE), France (FR), Germany (DE), Great Britain (GB), Italy (IT) Netherlands (NL), Spain (ES), Switzerland (CH),, Canada (CA), Hong Kong (HK), Australia (AU), New Zealand (NZ).
Product codes and lots: Part No. (PN) FAB-15004 (Box Lot Number)/Catalog No PRD-0400 (Box/Tray Lot Number) 285762 / 647288, 285765 / 647288, 286025 / 648958, 286026 / 648958, 286028 / 648959, 286852 / 650655, 287410 / 650656, 289297 / 648959, 290057 / 647288, 290068/654833, 290409 / 654833, 291425 / 657545

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1369-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1369-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-14	2021-04-07

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)