Z-1800-2018Class III

Syva EMIT II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440

Name: Z-1800-2018 Syva EMIT II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-03-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-03-12 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Syva EMIT II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440 on 2018-03-12. FDA classified it as Class III and gives the reason as "Incorrect calibrator level listed in qualitative calibration steps". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1800-2018
Classification: Class III
Status: Terminated
Initiated: 2018-03-12
Posted: 2018-05-10
Terminated: 2020-06-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Syva EMIT II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
Product code: DJG Enzyme Immunoassay, Opiates
Reason for recall: Incorrect calibrator level listed in qualitative calibration steps
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Siemens issued an Urgent Medical Device Correction (UMDC) in the U.S. and an Urgent Field Safety Notification (UFSN) in the OUS on 13-March-2018 to notify Syva Emit II Plus 6-Acetylmorphine customers that the calibrator on the Application Sheet is incorrect.
Distribution: PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1800-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1799-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10
Z-1800-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10

Product code DJG

K102779Class IIEmit II Plus6-Acetylmorphine Assay; Emit II Plus 6-Am/ Ecstasy Calibrator/ Control Level 1; Emit II Plus 6-Am / Ectasy CSiemens Healthcare Diagnostics, Inc. / cleared 2011-03-18

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)