CLASS II ONGOING Device recall · Reported 8 Dec 2021 · FDA Enforcement Report
Total Thyroxine (T4) Elisa recalled by DRG International
DRG International is recalling Total Thyroxine (T4) Elisa, distributed in Colorado, Delaware, New York. The recall was initiated on 18 Oct 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0310-2022
- FDA event ID
- 88949
- Recalling firm
- DRG International, Springfield, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Oct 2021
- FDA classified
- 29 Nov 2021
- Reported
- 8 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Oct 2021 | Recall initiated by company | |
| 29 Nov 2021 | Classified by FDA | +42 days |
| 8 Dec 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Total Thyroxine (T4) ELISA; REF EIA-1781
Where it was distributed
Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM
Questions about this recall
Why was it 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 lots are affected?
lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021
Where was it sold?
Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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