FDA Medical Device Recalls (openFDA)
Hologic, Inc: Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA
- Recall number
- Z-0750-2022
- Recalling firm
- Hologic, Inc
- Product
- Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA
- Status
- Open, Classified
- Initiated
- 2022-01-27
- Posted
- not on file
- Terminated
- not on file
- Reason
- Failed stability specifications for reagent kits that may result in false negative test results.
- Root cause
- Unknown/Undetermined by firm
- Action
- on 2/3/22 Hologic issued a "Urgent: Medical Device Recall Notification" via FedEx. In addition to informing consignees about the recall, the firm ask consignees to take the following action: 1. Immediately discontinue use of the lot of Panther Fusion Extraction Reagent-X kits and respective components 2. Immediately check their inventory and segregate the Panther Fusion Extraction Reagent-X kit lot 3. The number of kits shipped to the site is identified on the accompanying Customer Response Form (CRF). 4. Return the completed CRF to Hologic Technical Support, even if none of the kits remaining in the inventory. 5. If any of the specified kits remain in inventory (whether unopened or partial kits containing used reagent), to contact Hologic Technical Support. To destroy the segregated inventory After returning the completed CRF. 6. After returning the completed CRF, please destroy the segregated inventory. When this documentation is complete, please fax the CRF to Hologic Technical Support using this fax number: +1 858 410 8250. Alternatively, you can scan the document(s) and email to Hologic Technical Support at molecularsupport@hologic.com 8. If you have any questions or concerns regarding this recall notification, please contact Hologic Technical Support at +1 88 484 474 or +1 858410 8511 during the hours of 5 AM PDT - 5 PM PDT, or by e-mail at molecularsupport@hologic.com
- Quantity
- 264 kits
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, CA, CT, FL, GA, ID, IL, IN, MA, MD, ME, MI, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV, District of Columbia and the countries of Canada, Australia, Belgium, Netherlands, China, Italy, Germany, Sweden.
- Lot, serial or model codes
- Panther Fusion Extraction Reagent-X - Lot Numbers: 281375 and 291829 Components included within the kit: Panther Fusion Capture Reagent-X (FCR-X) - Lot Numbers: 281330 and 290312 Panther Fusion Enhancer Reagent-X (FER-X) - Lot Numbers281332 and 290331
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTW
- 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