CLASS II ONGOING Device recall · Reported 23 Mar 2022 · FDA Enforcement Report
Panther Fusion Extraction Reagent-X recalled by Hologic
Hologic is recalling Panther Fusion Extraction Reagent-X, distributed nationwide in the US. The recall was initiated on 27 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0750-2022
- FDA event ID
- 89533
- Recalling firm
- Hologic, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jan 2022
- FDA classified
- 11 Mar 2022
- Reported
- 23 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Jan 2022 | Recall initiated by company | |
| 11 Mar 2022 | Classified by FDA | +43 days |
| 23 Mar 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed stability specifications for reagent kits that may result in false negative test results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide ArkansasCaliforniaConnecticutDistrict of ColumbiaFloridaGeorgiaIdahoIllinoisIndianaMassachusettsMarylandMaineMichiganNew JerseyNevadaNew YorkOhioOregonPennsylvaniaTennessee
Questions about this recall
Why was it recalled?
Failed stability specifications for reagent kits that may result in false negative test results.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hologic
All 48| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 3dimensions Mammography System recalled by Hologic | Hologic | Other | Nationwide |
| Device | CLASS II | Selenia Dimensions Mammography Systems recalled by Hologic | Hologic | Other | Nationwide |
| Device | CLASS II | Genius" Review Station Display (Barco Monitor) recalled by Hologic | Hologic | Device Malfunction | Nationwide |
| Device | CLASS II | Aptima HPV Assay recalled by Hologic | Hologic | Potency & Assay | Nationwide |
| Device | CLASS II | Brevera Breast Biopsy System Disposable Needle recalled by Hologic | Hologic | Particulate Matter | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,671| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Techno-Path Multichem AE Unassayed Level recalled | Techno-path Manufacturing | Potency & Assay | Nationwide |
| Device | CLASS II | Techno-Path Multichem AE Unassayed Level recalled | Techno-path Manufacturing | Potency & Assay | Nationwide |
| Device | CLASS II | Techno-Path Multichem AE Unassayed Level recalled | Techno-path Manufacturing | Potency & Assay | Nationwide |
| Device | CLASS II | MAS Omni Immune PRO Liquid Assayed Integrated Immunoassay recalled | Microgenics | Potency & Assay | Nationwide |
| Device | CLASS II | The ABL90 Flex and ABL90 Flex Plus analyzers are intended recalled | Radiometer Medical ApS | Labeling Errors | Nationwide |