DRG International, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0310-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Total Thyroxine (T4) ELISA; REF EIA-1781

Product Classification:

Class II

Date Initiated: October 18, 2021

Date Posted: December 8, 2021

Recall Number: Z-0310-2022

Event ID: 88949

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.

Status: Ongoing

Product Quantity: 314 total (270 US)

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

Voluntary or Mandated:

Voluntary: Firm initiated