Z-1498-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 10, 2022
- Initiation Date
- June 28, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1614 units US ; 7,979 units OUS
Product Description
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
Reason for Recall
Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of AR, AU, AT, BS, BH, BD, BE, BR, BG, BF, CA, CL, CO, HR, CW, CZ, DK, EC, EG, EE, FI, FR, DE, GR, GP, HK, HU, IN, IR, IQ, IE, IL, IT, JP, JO, KE, KW, LV, LY, LT, MY, MX, MA, NL, NZ, NO, OM, CN, PK, PY, PE, PH, PL, PT, QA, KR, RO, RU, SA, RS, SG, SK, ZA, ES, SE, CH, TW, TH, TR, AE, UG, GB, UY, VA, VN.
Code Information
Unique Device Identification (UDI): 00630414596402 All lots