FDAClass IIAugust 21, 2024

BD Kiestra Urine Culture Application Powered by BD recall

BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;

Why was BD Kiestra Urine Culture Application Powered by BD recalled?

There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care.

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?

Catalog (Ref): 444900; UDI-DI: 00382904449001; Serial Numbers: IA00084, IA00054, IA00055, IA00088, IA00041, IA00071, IA00085, IA00007, IA00014, IA00005, IA00053, IA00073, IA00081, IA00011, IA00012, IA00027, SL01023, IA00026, IA00050, IA00034, IA00025, IA00086, IA00108,

Product
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Recalling firm
Becton Dickinson & Co.
Quantity
23 units
Distribution
US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA.
Recall date
August 21, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls