Panther(R) System recall
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Why was Panther(R) System recalled?
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number 20900001124
- Product
- Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
- Recalling firm
- Hologic, Inc
- Quantity
- 1 unit
- Distribution
- Indiana
- Recall date
- October 25, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)