Total Thyroxine (T4) ELISA; REF EIA-1781
Reported: December 8, 2021 Initiated: October 18, 2021 #Z-0310-2022
Product Description
Total Thyroxine (T4) ELISA; REF EIA-1781
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.
Details
- Recalling Firm
- DRG International, Inc.
- Units Affected
- 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
- Location
- Springfield, NJ
Frequently Asked Questions
What product was recalled? ▼
Total Thyroxine (T4) ELISA; REF EIA-1781. Recalled by DRG International, Inc.. Units affected: 314 total (270 US).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 8, 2021. Severity: Moderate. Recall number: Z-0310-2022.
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