CLASS II ONGOING Device recall · Reported 3 Jun 2020 · FDA Enforcement Report
Panther Fusion Extraction Reagent-S recalled by Hologic
Hologic is recalling Panther Fusion Extraction Reagent-S, distributed in 14 states. The recall was initiated on 10 Oct 2019 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-2163-2020
- FDA event ID
- 85346
- Recalling firm
- Hologic, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Oct 2019
- FDA classified
- 28 May 2020
- Reported
- 3 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Oct 2019 | Recall initiated by company | |
| 28 May 2020 | Classified by FDA | +231 days |
| 3 Jun 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
US: AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI OUS: AU, CA
ArkansasCaliforniaFloridaIdahoIllinoisIndianaLouisianaNew MexicoNew YorkPennsylvaniaTexasUtahWashingtonWisconsin
Questions about this recall
Is Panther Fusion Extraction Reagent-S recalled?
Yes. Hologic recalled Panther Fusion Extraction Reagent-S on 10 Oct 2019. The recall is Class II and its status is Ongoing. Recall number Z-2163-2020.
Why was it recalled?
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.
Which lots are affected?
Panther Fusion Extraction Reagent-S Lot number: 258402 Panther Fusion Capture Reagent-S Lot number: 257472 Panther Fusion Enhancer Reagent-S Lot number: 257473
Where was it sold?
US: AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI OUS: AU, CA
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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