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U.S. Department of Health and Human Services

Class 2 Device Recall EIA1781 Total Thyroxine (T4) ELISA

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  Class 2 Device Recall EIA1781 Total Thyroxine (T4) ELISA see related information
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
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
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.
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
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.
510(K) Database 510(K)s with Product Code = KLI and Original Applicant = BIOCHECK, INC.
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