Recall Z-0750-2022
Hologic, Inc · initiated January 27, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA
Codes / lots: Panther Fusion Extraction Reagent-X - Lot Numbers: 281375 and 291829 Components included within the kit: Panther Fusion Capture Reagent-X (FCR-X) - Lot Numbers: 281330 and 290312 Panther Fusion Enhancer Reagent-X (FER-X) - Lot Numbers281332 and 290331
Reason for recall
Failed stability specifications for reagent kits that may result in false negative test results.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
on 2/3/22 Hologic issued a "Urgent: Medical Device Recall Notification" via FedEx. In addition to informing consignees about the recall, the firm ask consignees to take the following action: 1. Immediately discontinue use of the lot of Panther Fusion Extraction Reagent-X kits and respective components 2. Immediately check their inventory and segregate the Panther Fusion Extraction Reagent-X kit lot 3. The number of kits shipped to the site is identified on the accompanying Customer Response Form (CRF). 4. Return the completed CRF to Hologic Technical Support, even if none of the kits remaining in the inventory. 5. If any of the specified kits remain in inventory (whether unopened or partial kits containing used reagent), to contact Hologic Technical Support. To destroy the segregated inventory After returning the completed CRF. 6. After returning the completed CRF, please destroy the segregated inventory. When this documentation is complete, please fax the CRF to Hologic Technical Support using this fax number: +1 858 410 8250. Alternatively, you can scan the document(s) and email to Hologic Technical Support at molecularsupport@hologic.com 8. If you have any questions or concerns regarding this recall notification, please contact Hologic Technical Support at +1 88 484 474 or +1 858410 8511 during the hours of 5 AM PDT - 5 PM PDT, or by e-mail at molecularsupport@hologic.com
Details
- Recall number
- Z-0750-2022
- Initiated
- January 27, 2022
- Product code
- JTW – System, Transport, Aerobic
- Quantity
- 264 kits
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, CA, CT, FL, GA, ID, IL, IN, MA, MD, ME, MI, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV, District of Columbia and the countries of Canada, Australia, Belgium, Netherlands, China, Italy, Germany, Sweden.
- Recalling firm
- Hologic, Inc, San Diego, CA