FDA Device recall Z-2323-2019
Kit BD Max ExK DNA 1 USA
- FDA Device
- Class II
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class II recall of Kit BD Max ExK DNA 1 USA by Becton Dickinson And, citing the foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2323-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-17 |
| Published | 2019-08-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Becton Dickinson And |
| 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 |
Product
Kit BD Max ExK DNA 1 USA; Catalog # 442817
Reason
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Identifiers
| code_info | Lot # 9085666; UDI (GTIN, DI+PI): (01)00382904428174 (17)201024(10)9085666(30)1; Exp: 10/24/2020 Lot #9106886; UDI (…Lot # 9085666; UDI (GTIN, DI+PI): (01)00382904428174 (17)201024(10)9085666(30)1; Exp: 10/24/2020 Lot #9106886; UDI (GTIN, DI+PI): (01)00382904428174 (17)201107(10)9106886(30)11; Exp: 11/7/2020 Lot #9127935; UDI (GTIN, DI+PI): (01)00382904428174 (17)201130(10)9127935(30)11; Exp: 11/30/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2323-2019%22
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