FDA Device recall Z-1674-2020
Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculatio…
- FDA Device
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculatio… by Beckman Coulter, citing due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible resul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1674-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-13 |
| Published | 2020-04-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.
Reason
Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results.
Identifiers
| code_info | Lot number 20201103T, Expiration Date: 11/3/2020 |
|---|
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-1674-2020%22
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