Z-2456-2024 Class II Ongoing
FDA device recall Z-2456-2024 was initiated by BioFire Diagnostics, LLC on June 19, 2024 and is designated Class II. Reason for recall: If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-vi… The recall status is ongoing. Affected quantity: 99,822.
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2024
- Initiation Date
- June 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99,822
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of FL, IL, KY, CO, KS, NC, AK, NY, ND, CA, TX, MD, GA, OH, WI, SD, LA, MT, VA, IA, MO, MA, WV, NE, OK, AZ, OR, SC, MI, IN, ID, TN, WA, NM, NJ, AR, AL, MN, NH, NV, PA, WY, MS, CT and the countries of AE, AM, AR, AT, BA, BG, BH, BN, BR, CA, CH, CI, CK, CN, CO, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GA, GB, GE, GR, GT, HR, HU, IL, IN, IQ, IS, IT, JO, JP, KK, KR, KW, LB, LT, LV, MK, MM, MX, MY, NG, NO, NW, OM, PA, PH, PK, PL, PT, QA, RO, RS, SA, SI, TN, TR, TW, UG, UY, VN, WF.