Z-0750-2022Class II

Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only...

Name: Z-0750-2022 Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only...
Creator: Hologic, Inc
Published: 2022-01-27
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2022-01-27 / Open, Classified

FDA source

Hologic, Inc began a recall of 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... on 2022-01-27. FDA classified it as Class II and gives the reason as "Failed stability specifications for reagent kits that may result in false negative test results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0750-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-27
Posted: 2022-03-11
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
Product code: JTW System, Transport, Aerobic
Reason for recall: Failed stability specifications for reagent kits that may result in false negative test results.
FDA 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 [email protected] 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 [email protected]
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0750-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0750-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11

Product code JTW

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)