DRG International, Inc. Recall 88949
Description: Total Thyroxine (T4) ELISA; REF EIA-1781
DRG International, Inc. Recall 88949 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0310-2022 |
| Event ID | 88949 |
| Event Description | Total Thyroxine (T4) ELISA; REF EIA-1781 |
| Product Type | Devices |
| Distribution | Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM |
| Quantity | 314 total (270 US) |
| Recall Reason | 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. |
| Device Classification | 20211208 |
| Device Code Info | lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021 |
| Center Classification Date | 20211129 |
| Recall Initiation Date | 20211018 |
| Recalling Firm | DRG International, Inc. |
| Initial Notification | |
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