ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Summary
The FDA issued a Class II for ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the Un by Remel Inc. Reason: Out of Specification.
Details
Source
Device Recall
External ID
Z-2142-2021
Action Date
2021-08-04
Status
Terminated
Category
device
Product Description
ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Lot/Code Info: Model: CT0223B Lots#'s: 2341375, 2343397, 2394162, 2403210, 2438023, 2463120, 2408058, 2438086, 2457651, 2832507, 2840771, 2935065, 2958576, 2968037 and 2978564 UDI-DI: 05032384006533
Quantity Affected: 327 units
Reason for Recall
Out of Specification
Distribution
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Hawaii and Puerto Rico. The countries of BERMUDA.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-18
Company
Lenexa, KS
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 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Remel Inc has 25 FDA actions in our database, including 25 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 (Remel Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Remel Inc have FDA actions?
Remel Inc has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2142-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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