Summary
The FDA issued a Class II for Total Thyroxine (T4) ELISA; REF EIA-1781 by DRG International, Inc.. 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 diagn.
Details
Source
Device Recall
External ID
Z-0310-2022
Action Date
2021-12-08
Status
Ongoing
Category
device
Product Description
Total Thyroxine (T4) ELISA; REF EIA-1781
Lot/Code Info: lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021
Quantity Affected: 314 total (270 US)
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.
Distribution
Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-18
Company
Springfield, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 131 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DRG International, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DRG International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DRG International, Inc. have FDA actions?
DRG International, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0310-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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