High FDA (Devices)·Z-0595-2018·Announced 2018-02-21

Hologic Panther Fusion Recalled Due to Falling Glass Panel Hazard

Hologic is recalling 103 Panther Fusion instruments because the glass panel may separate from the monitor and fall, potentially striking an operator.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where the glass panel could fall and hit an operator, but no injuries have been reported in the source text.

Plain-English summary

Hologic, Inc. is recalling 103 units of the Hologic Panther(R) Fusion(TM) instrument, catalog number ASY-09600. The recall is due to a defect where the glass panel may separate from the 19-inch touch screen monitor. If the panel separates, it could potentially fall and hit an operator.

The affected units were distributed worldwide. The recall includes specific serial numbers listed in the official FDA record. The Panther Fusion is a fully automated sample-to-result instrument used for nucleic acid testing.

Hologic is the recalling firm. Users of these instruments should contact Hologic for instructions on how to address the defect.

The recalled product

Product: Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Pa
Manufacturer: Hologic, Inc
Category: Medical Device — Laboratory Equipment
Hazard: falling-object
impact-injury
Affected units: 103

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial Numbers: 2090002307
2090002308
2090002309
2090002310
2090002311
2090002312
2090002339
2090002340
2090002341
2090002342
2090002343
2090002344
2090002345
2090002346
2090002347
2090002348
2090002349
2090002350
2090002351
2090002352

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Hologic, Inc

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