| Class 2 Device Recall EIA1781 Total Thyroxine (T4) ELISA |  |
Date Initiated by Firm | October 18, 2021 |
Create Date | November 29, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0310-2022 |
Recall Event ID |
88949 |
510(K)Number | K991432 |
Product Classification |
Enzyme immunoassay, non-radiolabeled, total thyroxine - Product Code KLI
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Product | Total Thyroxine (T4) ELISA; REF EIA-1781 |
Code Information |
lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021 |
Recalling Firm/ Manufacturer |
DRG International, Inc. 841 Mountain Ave Springfield NJ 07081-3437
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For Additional Information Contact | Ina Hairston 973-564-7555 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 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.
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Quantity in Commerce | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = KLI
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