FDAClass IIAugust 28, 2019

Kit BD Max Enteric Bacterial Panel EU recall

Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963

Why was Kit BD Max Enteric Bacterial Panel EU recalled?

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Lot # 9085672; UDI (GTIN, DI+PI):(01)00382904429638 (17)201011(10)9085672(30)1; Exp:10/11/2020 Lot # 9085673; UDI (GTIN, DI+PI):(01)00382904429638 (17)201011(10)9085673(30)1; Exp:10/11/2020 Lot # 9106961; UDI (GTIN, DI+PI): (01)00382904429638 (17)201011(10)9106961(30)1; Exp:10/11/2020 Lot # 9106962; UDI (GTIN, DI+PI): (01)00382904429638 (17)201102(10)9106962(30)1; Exp:11/2/2020

Product
Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963
Recalling firm
Becton Dickinson & Co.
Quantity
994 units
Distribution
AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan
Recall date
August 28, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls