Z-1260-2020 Class II Terminated
FDA device recall Z-1260-2020 was initiated by Siemens Healthcare Diagnostics, Inc. on November 19, 2019 and is designated Class II. Reason for recall: Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery. The recall status is terminated (terminated August 30, 2021). Affected quantity: 844.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- November 19, 2019
- Termination Date
- August 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 844
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WY and countries of UK, CA, PH, MX, VN, TW, TH, IN, CO, AE, AR, AU, BD, BE, BG, BR, CL, CZ, DE, DK, EG, ES, FI, FR, GR, HU, IE, IT, KR, MY, NL, PL, PT, RO, RU, SE, SG.