Total Thyroxine (T4) ELISA; REF EIA-1781
- Company
- Drg International, Inc.
- Recall Initiated
- October 18, 2021
- Recall Number
- Z-0310-2022
- Quantity
- 314 total (270 US)
- Firm Location
- Springfield, NJ
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
Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM
Lot / Code Info
lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021
Root Cause
Nonconforming Material/Component
Action Taken
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 and notify the appropriate regulatory bodies as required. 4) Disposal of all affected lots should be in accordance with applicable national, st ate, and local laws and regulations. 5) Complete and return the response form.