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DRG International, Inc. Recall 88949

Description: Total Thyroxine (T4) ELISA; REF EIA-1781

DRG International, Inc. Recall 88949 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0310-2022
Event ID88949
Event DescriptionTotal Thyroxine (T4) ELISA; REF EIA-1781
Product TypeDevices
DistributionDomestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM
Quantity314 total (270 US)
Recall ReasonFirm 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.
Device Classification20211208
Device Code Infolot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021
Center Classification Date20211129
Recall Initiation Date20211018
Recalling FirmDRG International, Inc.
Initial Notification E-Mail
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