Z-2438-2018Class II

Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586

Name: Z-2438-2018 Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-03-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-03-21 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586 on 2018-03-21. FDA classified it as Class II and gives the reason as "The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2438-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-21
Posted: 2018-07-13
Terminated: 2020-06-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586
Product code: CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Reason for recall: The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.
FDA root cause: Under Investigation by firm
Action: Notification letters were distributed 3/21/18. The letters instructed customers to: Inspect stock, discontinue use of and discard the Dimension Vista Diluent lots listed in Table 1. Please review this letter with your Medical Director. Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens Technical Support Representative. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product.
Quantity in commerce: 1195
Distribution: The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to Guam, Saipan, and Virgin Islands. The products were distributed to the following countries: Australia, Austria, Bahamas, Belgium, Brazil, Canada, Canary Islands, Croatia, Czech Republic, Denmark, France, Germany, Italy, Japan, Lebanon, Netherlands, Poland, Portugal, Qatar, Russian Federation, Slovakia, Slovenia, Saudi Arabia, South Korea, Spain, Switzerland, and United Arab Emirates.
Product codes and lots: lot 7CDA79, UDI # (UDI) 008427680324177CDA7918090110483586, exp 2018-09-01; lot # 7DDA70, UDI # (UDI) 008427680324177DDA7018110110483586, exp 2018-11-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2438-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2436-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-13
Z-2437-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-13
Z-2438-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-13

Product code CDZ

K151529Class IDimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone CalibratorSiemens Healthcare Diagnostics, Inc. / cleared 2016-02-11

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)