Recall Z-0310-2022— DRG International, Inc.

Name: FDA recall Z-0310-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-18

Class II · Ongoing

Class II FDA medical device recall by DRG International, Inc., initiated 2021-10-18. It names one FDA 510(k) clearance: K991432. Product: Total Thyroxine (T4) ELISA; REF EIA-1781. 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..

Recalling firm: DRG International, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-10-18
Firm location: Springfield, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K991432 — BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007Biocheck, Inc.·cleared 1999-06-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Total Thyroxine (T4) ELISA; REF EIA-1781

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.