Hologic, Inc Recall 87557
Description: Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.
Hologic, Inc Recall 87557 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1369-2021 |
| Event ID | 87557 |
| Event Description | Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, IN, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, TX, UT, VA, VT, WA, WI, WV and the countries of Austria (AT), Belgium (BE), France (FR), Germany (DE), Great Britain (GB), Italy (IT) Netherlands (NL), Spain (ES), Switzerland (CH),, Canada (CA), Hong Kong (HK), Australia (AU), New Zealand (NZ). |
| Quantity | 1355 kits |
| Recall Reason | There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results. |
| Device Classification | 20210414 |
| Device Code Info | Part No. (PN) FAB-15004 (Box Lot Number)/Catalog No PRD-0400 (Box/Tray Lot Number) 285762 / 647288, 285765 / 647288, 286025 / 648958, 286026 / 648958, 286028 / 648959, 286852 / 650655, 287410 / 650656, 289297 / 648959, 290057 / 647288, 290068/654833, 290409 / 654833, 291425 / 657545 |
| Center Classification Date | 20210407 |
| Recall Initiation Date | 20210226 |
| Recalling Firm | Hologic, Inc |
| Initial Notification | Letter |
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