Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
Summary
The FDA issued a Class II for Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis by Mckesson Medical-Surgical Inc. Corporate Office. Reason: Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the val.
Details
Source
Device Recall
External ID
Z-1311-2024
Action Date
2024-03-27
Status
Ongoing
Category
device
Product Description
Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
Lot/Code Info: Catalogue Number: 184; Lot No. CK233;
Quantity Affected: 1 unit
Reason for Recall
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes .
Distribution
US Nationwide distribution in the states of AZ, PA and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-09
Company
Richmond, VA
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 158 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA actions in our database, including 276 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 (Mckesson Medical-Surgical Inc. Corporate Office) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mckesson Medical-Surgical Inc. Corporate Office have FDA actions?
Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA actions in our database, including 276 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1311-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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