Z-0310-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 8, 2021
- Initiation Date
- October 18, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 314 total (270 US)
Product Description
Total Thyroxine (T4) ELISA; REF EIA-1781
Reason for Recall
Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.
Distribution Pattern
Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM
Code Information
lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021