Z-1939-2020Class II

SWIN 2017 database, Model YSW4000

Name: Z-1939-2020 SWIN 2017 database, Model YSW4000
Creator: Remel Inc.
Published: 2019-01-04
License: https://open.fda.gov/license/

Trek Diagnostic Systems, Ltd. / initiated 2019-01-04 / Terminated / root cause: software

FDA source

Remel Inc. began a recall of SWIN 2017 database, Model YSW4000 on 2019-01-04. FDA classified it as Class II and gives the reason as "Potential for out of range microbial results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1939-2020
Classification: Class II
Status: Terminated
Initiated: 2019-01-04
Posted: 2020-05-08
Terminated: 2020-08-17
Recalling firm: Trek Diagnostic Systems, Ltd.
Product: SWIN 2017 database, Model YSW4000
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: Potential for out of range microbial results
Root cause tag: software
FDA root cause: Software design
Action: Technicians replaced YSW514-17 with YSW514-17A.
Quantity in commerce: 250
Distribution: ...
Product codes and lots: ...

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1939-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1939-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-08

Product code LON

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)