Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Summary
The FDA issued a Class II for Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD for by Remel Inc. Reason: There are lower than expected MICs for some gram negative species..
Details
Source
Device Recall
External ID
Z-0722-2022
Action Date
2022-03-16
Status
Ongoing
Category
device
Product Description
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Lot/Code Info: Product Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expiration 2022/May24) 4) B1161A (Expiration 2022/Apr19 5) B0361 (Expiration 2021/Aug31) 6) B0164B (Expiration 2021/Apr16)
Quantity Affected: 1210 devices
Reason for Recall
There are lower than expected MICs for some gram negative species.
Distribution
Distribution throughout the United States.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-10
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 143 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-0722-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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