Z-1513-2020 Class II Terminated
FDA device recall Z-1513-2020 was initiated by Siemens Healthcare Diagnostics, Inc. on February 5, 2020 and is designated Class II. Reason for recall: Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when t… The recall status is terminated (terminated November 18, 2021). Affected quantity: 2267 kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- February 5, 2020
- Termination Date
- November 18, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2267 kits
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, MI, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI. SC, TN, TX, UT, VA, WA, WI, WY, and countries of AE, AF, AL, AO, AR, AT, AU, AZ, BD, BE, BO, BG, BH, BR, CA, CH, CO, CL, CN, CO, CR, CY, DE, DO, DZ, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, IE, IN, IR, IS, IT, IQ, JO, KE, KR, LB, LT, LV, LY, ME, MK, MX, NL, NO, PA, PE, PH, PK, PL, PS, PT, PY, QA, RO, RU, SA, SE, SK, SL, SV, SY, TH, TJ, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XK, XS, ZA