Z-2327-2019 Class II Terminated
FDA device recall Z-2327-2019 was initiated by Becton Dickinson & Co. on Jul 17, 2019 and is designated Class II. Reason for recall: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. The recall status is terminated (terminated May 13, 2020). Affected quantity: 86 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 28, 2019
- Initiation Date
- Jul 17, 2019
- Termination Date
- May 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 86 units
Product Description
Kit BD Max ExK TNA 2; Catalog # 442825
Reason for Recall
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Distribution Pattern
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
Code Information
Lot # 9106876; UDI (GTIN, DI+PI): (01)00382904428259 (17)201107(10)9106876(30)1; Exp: 11/7/2020
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2327-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026