Z-1369-2021 Class II Ongoing
FDA device recall Z-1369-2021 was initiated by Hologic, Inc on February 26, 2021 and is designated Class II. Reason for recall: There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results. The recall status is ongoing. Affected quantity: 1355 kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- February 26, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1355 kits
Product Description
Reason for Recall
Distribution Pattern
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).