FDAClass IIMarch 27, 2024

Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial recall

Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis

Why was Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial recalled?

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 .

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalogue Number: 184; Lot No. CK233;

Product
Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Quantity
1 unit
Distribution
US Nationwide distribution in the states of AZ, PA and TX.
Recall date
March 27, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls