FDA Device recall Z-1373-2021
MicroScan WalkAway-96 plus Reconditioned Instrument
- FDA Device
- Class II
- terminated
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of MicroScan WalkAway-96 plus Reconditioned Instrument by Beckman Coulter, citing instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Contro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1373-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-04 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | CO, FL, IL, IN, KY, ME, MI, MS, PA, PR, TN, TX, UT, VA, WA |
Product
MicroScan WalkAway-96 plus Reconditioned Instrument
Reason
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.
Identifiers
| code_info | Catalog Number: B1018-396R UDI Code: 15099590684129 Serial Numbers: 3967245 3967417 3967493 3967544 3967634 3967734 3967914 3928224 3968442 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1373-2021%22
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