BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitativ
Summary
The FDA issued a Class II for BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catal 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-1012-2024
Action Date
2024-02-14
Status
Ongoing
Category
device
Product Description
BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
Lot/Code Info: Catalog No. 230705 UDI-DI 00382902307051 Lots 1301474 1334111 2025840 2146318 2242344 2276051 2333100 3150355 3234179 ; Catalog No. 231264¿ UDI-DI 30382902312643 Lots 2333100 3030225 3058510 3150355 3234179 3282314 1301474 1334111 2003260 2025840 2146318 2242344 2276051; Catalog No. 231263 UDI-DI 30382902312636 Lots 3010977 3058508 3184064 3234190 1302042 2003517 2146414 2243865 2277199 2339360
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-1012-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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