Reported Oct 25, 2017 · Terminated
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 10210 Genetic Center Dr · San Diego, CA · 92121-4362
Is this the product you have?
- Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
- Lot codes and dates
- Serial Number 20900001124
- Amount recalled
- 1 unit
Where it was sold
Why it was recalled
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
This product could cause temporary or reversible health problems — stop using it.
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