Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-q
Summary
The FDA issued a Class II for Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 2 by Becton Dickinson & Co.. Reason: There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause p.
Details
Source
Device Recall
External ID
Z-1011-2024
Action Date
2024-02-14
Status
Ongoing
Category
device
Product Description
Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing
Lot/Code Info: Catalog No. 231628 UDI-DI 00382902316282 Lots 2090490 2146520 2210201 2276143 3062095; Catalog No. 231629¿¿ UDI-DI 30382902316290 Lots 3163306 3163307 3163310 3254307 3254309 3271840 3271853 2146520 2146526 2147225 2210201 2224295 2276143 2276144 3003894 3062095 3090649
Quantity Affected: 2,363,168 total units
Reason for Recall
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
Distribution
Domestic distribution nationwide. International distribution worldwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-08
Company
Sparks, MD
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 274 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Becton Dickinson & Co. has 73 FDA actions in our database, including 73 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 (Becton Dickinson & Co.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson & Co. have FDA actions?
Becton Dickinson & Co. has 73 FDA actions in our database, including 73 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1011-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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