Recall Z-0310-2022 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
DRG International, Inc.
Total Thyroxine (T4) ELISA; REF EIA-1781
| Date | Oct 18, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 10/18/2021, DRG issued Medical Device Recall Notification letters and response forms to the End-user through confirmation of the Distributor. All customers were notified via e-mail. Actions Required: 1) Please immediately discontinue use or distribution of the affected lots. 2) If you have further distributed the affected product lots, please identify and immediately notify those customers at once of this product recall by providing a copy of the recall notice and response form. 3) If you have relabeled or rebranded the affected product lots, please follow your internal recall process a |
| Quantity | 314 total (270 US) |
| Distribution | Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991432 | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 Biocheck, Inc., Jun 2, 1999 |