Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Reported: October 25, 2017 Initiated: September 15, 2017 #Z-0027-2018
Product Description
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Reason for Recall
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
Details
- Recalling Firm
- Hologic, Inc
- Units Affected
- 1 unit
- Distribution
- Indiana
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use. Recalled by Hologic, Inc. Units affected: 1 unit.
Why was this product recalled? ▼
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 25, 2017. Severity: Moderate. Recall number: Z-0027-2018.
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