Z-0617-2016Class II

Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus...

Name: Z-0617-2016 Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus...
Creator: Siemens Healthcare Diagnostics Inc
Published: 2015-11-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-11-11 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care rM ~ h CG method Catalog Number... on 2015-11-11. FDA classified it as Class II and gives the reason as "Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0617-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-11
Posted: 2016-01-07
Terminated: 2016-09-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061
Product code: DHA System, Test, Human Chorionic Gonadotropin
Reason for recall: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on November 11, 2015 both in the United States and internationally for communication with affected customers. This notice informs customers of the issue and provides mitigation instructions. Customers with questions were advised to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding call 781-269-3000.
Quantity in commerce: 196
Distribution: Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
Product codes and lots: Lot Numbers: 625229002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0617-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0609-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0610-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0611-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0612-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0613-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0614-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0615-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0616-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0617-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0618-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0619-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07

Product code DHA

K060548Class IIStratus Cs Acute Care Betahcg and Nt-Probnp Testpak and Testpak Assay, Calpak and DilpakDade Behring, Inc. / cleared 2006-04-06

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)