Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
- Company
- Hologic, Inc
- Recall Initiated
- November 8, 2024
- Posted
- December 20, 2024
- Recall Number
- Z-0694-2025
- Quantity
- 3
- Firm Location
- San Diego, CA
Reason for Recall
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Distribution
US: AK
Lot / Code Info
UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494
Root Cause
Unknown/Undetermined by firm
Action Taken
On 11/8/24, recall notices were mailed to customers asking them to do the following: 1) Discontinue use, and discard affected kits. 2) Complete and return the customer response firm via email to molecularsupport@hologic.com If you require technical support, contact the firm's Technical Support at 1-888-484-4747, or 1-858-410-8511, or molecularsupport@hologic.com
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