Z-0310-2022Class II

Total Thyroxine (T4) ELISA; REF EIA-1781

Name: Z-0310-2022 Total Thyroxine (T4) ELISA; REF EIA-1781
Creator: DRG International, Inc.
Published: 2021-10-18
License: https://open.fda.gov/license/

DRG International, Inc. / initiated 2021-10-18 / Open, Classified / root cause: manufacturing process

FDA source

DRG International, Inc. began a recall of Total Thyroxine (T4) ELISA; REF EIA-1781 on 2021-10-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0310-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-18
Posted: 2021-11-29
Recalling firm: DRG International, Inc.
Product: Total Thyroxine (T4) ELISA; REF EIA-1781
Product code: KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
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.
Root cause tag: manufacturing process
FDA 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 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
Product codes and lots: lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0310-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0310-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-08	2021-11-29

Product code KLI

K991432Class IIBiocheck Total T4 Enzyme Immunoassay Test Kit, Model Bc-1007Biocheck, Inc. / cleared 1999-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)