MicroScan WalkAway-96 plus Instrument — Class II medical device recall Z-1371-2021
Terminated recall by Beckman Coulter Inc., reported 2021-04-14, distributed in CO, FL, IL, IN, KY, ME, MI, MS…. Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispen
| Recall number | Z-1371-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2019-09-04 |
| Classified | 2021-04-07 |
| Reported by FDA | 2021-04-14 |
| Terminated | 2023-01-11 |
| Distributed | CO, FL, IL, IN, KY, ME, MI, MS, PA, PR, TN, TX, UT, VA, WA |
| Countries outside the US | ID, IN, IT, JP, KR, PH, PL, RU, TW |
| Quantity | 12 systems |
| UPC / GTIN / UDI-DI | 15099590658687 |
| Serial numbers | 39610001, 39610002, 39610003, 39610004, 39610005, 39610006, 39610007, 39610008, 39610009, 39610010, 39610011, 39610012 |
| Model numbers | B1018-284 |
Product
MicroScan WalkAway-96 plus Instrument
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1371-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.