Z-0387-2018Class II

Phadia 1000 Instrument, Article Number 12-3800-01

Name: Z-0387-2018 Phadia 1000 Instrument, Article Number 12-3800-01
Creator: Phadia US Inc
Published: 2017-07-05
License: https://open.fda.gov/license/

Phadia AB / initiated 2017-07-05 / Terminated / root cause: design

FDA source

Phadia US Inc began a recall of Phadia 1000 Instrument, Article Number 12-3800-01 on 2017-07-05. FDA classified it as Class II and gives the reason as "The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0387-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-05
Posted: 2018-01-18
Terminated: 2018-10-04
Recalling firm: Phadia AB
Product: Phadia 1000 Instrument, Article Number 12-3800-01.
Product code: DHB System, Test, Radioallergosorbent (Rast) Immunological
Reason for recall: The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent letters with a return response form to customers. The firm instructed customers to immediately choose the "stop" command if presented with the 7-101 Liquid Sensor Error. Results from the assay should not be approved. A revision of the current software will have a mandatory installation soon.
Quantity in commerce: 70 units
Distribution: Nationwide
Product codes and lots: All versions of the instrument

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0387-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0387-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-18

Product code DHB

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)