CLASS II Device recall · Reported 25 Oct 2017 · FDA Enforcement Report
Panther(R) System recalled by Hologic
Hologic is recalling Panther(R) System, distributed in Indiana. The recall was initiated on 15 Sep 2017 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-0027-2018
- FDA event ID
- 78216
- Recalling firm
- Hologic, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Sep 2017
- FDA classified
- 18 Oct 2017
- Reported
- 25 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Sep 2017 | Recall initiated by company | |
| 18 Oct 2017 | Classified by FDA | +33 days |
| 25 Oct 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) 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(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Where it was distributed
Indiana
Questions about this recall
Is Panther(R) System recalled?
Yes. Hologic recalled Panther(R) System on 15 Sep 2017. The recall is Class II and its status is Terminated. Recall number Z-0027-2018.
Why was it recalled?
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
Which lots are affected?
Serial Number 20900001124
Where was it sold?
Indiana
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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