Reported Dec 8, 2021 · Ongoing

Total Thyroxine (T4) ELISA; REF EIA-1781

DRG International, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DRG International, Inc. · 841 Mountain Ave · Springfield, NJ · 07081-3437

Is this the product you have?

    • Total Thyroxine (T4) ELISA
    • REF EIA-1781
Lot codes and dates
    • lot#: RN-60923 expiration date 12/31/2021
    • RN-60831 expiration date 12/31/2021
Amount recalled
314 total (270 US)

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 PM UTC

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