FDA Medical Device Recalls (openFDA)
Hologic, Inc: 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.
- Recall number
- Z-1369-2021
- 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.
- Status
- Open, Classified
- Initiated
- 2021-02-26
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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 molecularsupport@hologic.com
- Quantity
- 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).
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NSU
- Firm FEI
- 2024800
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28