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Recall Observatory FDA recall evidence

Device product

Total Thyroxine (T4) ELISA; REF EIA-1781

Z-0310-2022

October 18, 2021

Class II

Product summary

Firm
DRG International, Inc.
Event
Event 88949
Status
Ongoing
Classification
Class II
Quantity
314 total (270 US)
Official record key
device-enforcement:Z-0310-2022

Official wording

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.

Code information: lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021

Distribution pattern: Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.