Z-2610-2017Class II

Dimension Vista Prolactin (PRL) Flex reagent cartridge

Name: Z-2610-2017 Dimension Vista Prolactin (PRL) Flex reagent cartridge
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2017-03-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-03-21 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista Prolactin (PRL) Flex reagent cartridge on 2017-03-21. FDA classified it as Class II and gives the reason as "The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH...". 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-2610-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-21
Posted: 2017-05-05
Terminated: 2018-08-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista Prolactin (PRL) Flex reagent cartridge
Product code: CFT Radioimmunoassay, Prolactin (Lactogen)
Reason for recall: The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Siemens mailed an Urgent Medical Device Correction Letter to affected customers on 03/29/2017 to inform them of the issue. The notice explained the reason for the field action, Risk to Health and actions to be taken by the customer.
Quantity in commerce: 3,443 units
Distribution: Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa
Product codes and lots: Device Listing Number # A836016 Lot # 16112BB, 16148BA,16165BE,16195BA,16223AD,16259BC 16285BE,16312BD,16334BE,17004BA,17038BC

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2610-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2606-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-16
Z-2607-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-16
Z-2608-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-16
Z-2609-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-16
Z-2610-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-16
Z-2611-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-16

Product code CFT

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)