FDA Device recall Z-2338-2019
Kit EXT Enteric Bacterial Panel
- FDA Device
- Class II
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class II recall of Kit EXT Enteric Bacterial Panel 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-2338-2019 |
| 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 EXT Enteric Bacterial Panel; Catalog # 443812
Reason
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Identifiers
| code_info | Lot # 9114557; UDI (GTIN, DI+PI): (01)00382904438128 (17)201107(10)9114557(30)1; Exp: 11/7/2020 Lot # 9126778; UDI (…Lot # 9114557; UDI (GTIN, DI+PI): (01)00382904438128 (17)201107(10)9114557(30)1; Exp: 11/7/2020 Lot # 9126778; UDI (GTIN, DI+PI): (01)00382904438128 (17)201117(10)9126778(30)1; Exp: 11/17/2020 Lot # 9129979; UDI (GTIN, DI+PI): (01)00382904438128 (17)201122(10)9129979(30)1; Exp: 11/22/2020 |
|---|
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-2338-2019%22
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