medical MODERATE Updated 2017-10-25

Hologic, Inc recalls Panther(R) System, Catalog Number 902615, For Use with Holog

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Recalled Product

Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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Hazard / Issue

An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.

Issued by

FDA

Distribution: Indiana
Lot/Code Info: Serial Number 20900001124

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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