Z-1261-2020 Class II Terminated
FDA device recall Z-1261-2020 was initiated by Siemens Healthcare Diagnostics, Inc. on November 19, 2019 and is designated Class II. Reason for recall: Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica¿ CH Analyzer. The recall status is terminated (terminated August 30, 2021). Affected quantity: 1306.
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
- 1306
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.