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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Hologic, Inc
- 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.
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