Z-2163-2020Class II

Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture...

Name: Z-2163-2020 Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture...
Creator: Hologic, Inc
Published: 2019-10-10
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2019-10-10 / Open, Classified / root cause: manufacturing process

FDA source

Hologic, Inc began a recall of Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and... on 2019-10-10. FDA classified it as Class II and gives the reason as "Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false...". 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-2163-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-10-10
Posted: 2020-05-28
Recalling firm: Hologic, Inc.
Product: Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
Reason for recall: Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customers who received product/affected lot were to be contacted via Urgent: Medical Device Recall Notification Letter, dated October 10, 2019 via FedEx overnight. In addition to notifying customers about the recall, the recall notification asked customers to take the following actions: 1) Immediately discontinue use of the lot of Panther Fusion Extraction Reagent-S kits and respective components listed in Table 1. 2) Immediately check inventory and segregate the Panther Fusion Extraction Reagent-S kit lot listed in Table 1. 3) Notified customers of the numbers of kits shipped to customers' site on Customer Response Form. Requested customers complete CRF per the accompanying instructions after segregation of affected product. 4) Requested customers return the completed CRF to Hologic Technical Support, even if they do not have any of the listed kits remaining in their inventory. 5) If customers identified any of the specified kits remaining in inventory (whether unopened or partial kits containing used reagent), requested they contact their technical support using the contact information provided for a replacement. One replacement kit was shipped proactively to minimize downtime due to this issue. 6) After completing the CRF, customers were instructed to destroy the segregated inventory and fax the documentation to the Hologic Technical Support using the fax number +1 858 410 8250 or scan the document(s) and email to Hologic Technical Support at [email protected]. If customers had any questions or concerns regarding the recall notification, they were to contact Hologic Technical Support at +1 888 484 4747 or +1 858 410 8511 during the hours of 5 am PDT and 5 pm PDT, or by email [email protected]
Quantity in commerce: 47 kits
Distribution: US: AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI OUS: AU, CA
Product codes and lots: Panther Fusion Extraction Reagent-S Lot number: 258402 Panther Fusion Capture Reagent-S Lot number: 257472 Panther Fusion Enhancer Reagent-S Lot number: 257473

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2163-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2163-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-28

Product code OCC

K171963Class IIPanther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis TubesHologic, Inc. / cleared 2017-09-26

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)