Total Thyroxine recall
Total Thyroxine (T4) ELISA; REF EIA-1781
Why was Total Thyroxine recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021
- Product
- Total Thyroxine (T4) ELISA; REF EIA-1781
- Recalling firm
- DRG International, Inc.
- 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
- Recall date
- December 8, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)