FDA Medical Device Recalls (openFDA)
DRG International, Inc.: Total Thyroxine (T4) ELISA; REF EIA-1781
- Recall number
- Z-0310-2022
- Recalling firm
- DRG International, Inc.
- Product
- Total Thyroxine (T4) ELISA; REF EIA-1781
- Status
- Open, Classified
- Initiated
- 2021-10-18
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021
- 510(k) numbers
- ["K991432"]
- PMA numbers
- not on file
- Product code
- KLI
- Firm FEI
- 2245285
- Firm city
- Springfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28