Recall Z-1369-2021 ยท NSU Instrumentation For Clinical Multiplex Test Systems
Hologic, Inc
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.
| Date | Feb 26, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On February 26, 2021, Hologic, issued "Urgent: Medical Device Recall Notification" to affected consignees via FedEx. In addition, to informing consignees about the recall, they asked customers to take the following actions: Laboratory Action: A. Please immediately discontinue use of the Panther Fusion Tube Tray lots listed in Table 1. B. Please immediately check your inventory and segregate the Panther Fusion Tube Tray lots listed in Table 1. C. The number of tube tray boxes shipped to your site is identified on the accompanying document. (GBS customers will receive a blank form and will n |
| Quantity | 1355 kits |
| 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 (I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.