Recall Z-0214-2022 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
BioCheck, Inc.
T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
| Date | Nov 10, 2021 (initiated Oct 14, 2021) |
| Status | Terminated |
| Reason | Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls. |
| Root cause | Component change control |
| Action | On October 14, 2021 BioCheck issued a "Medical Device Recall Notification" to affected customers. In addition to informing consignees about the recall, BioCheck asked consignees to take the following actions: 1) Please immediately discontinue use or distribution of the affected lots. 2) If you have further distributed the affected product lots, please identify those customers and notify them at once of this product recall. 3) If you have relabeled or rebranded the affected product lots, please follow your internal recall process and notify appropriate regulatory bodies, if required. 4) Dis |
| Quantity | 314 kits |
| Distribution | US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria |
| 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 |