Z-2514-2024 Class II Ongoing
FDA device recall Z-2514-2024 was initiated by BioFire Diagnostics, LLC on May 16, 2024 and is designated Class II. Reason for recall: Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. The recall status is ongoing. Affected quantity: 67,613 kits (or 2,028,309 pouches). Each pouch is used for each individual test..
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2024
- Initiation Date
- May 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67,613 kits (or 2,028,309 pouches). Each pouch is used for each individual test.
Product Description
Reason for Recall
Distribution Pattern
U.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and WY. O.U.S.: Worldwide - AR, AU, AT, BE, BR, CA, CL, HK, CN, CO, CZ, DE, FI, FR, GR, HU, IN, IT, JP, MX, NL, NO, PH, PL, PT, SG, ZA, KR, ES, SE, CH, TW, TH, TR, GB, AL, DZ, AO, AM, BH, BY, BO, BA, BW, BG, CR, HR, CY, CD, DO, AN, EC, SV, EE, FJ, GE, GU, GT, GN, HT, HN, IS, ID, IQ, IE, IL, CI, CI, JO, KE, KW, LV, LB, LT, MO, MY, ML, MR, MD, MN, MA, MM, NP, NZ, NZ, NI, OM, PK, PA, PG, PY, PE, QA, RO, SA, RS, SI, TN, TR, UY, AE, VE, VN, and ZW.