Z-1925-2013Class II

Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme...

Name: Z-1925-2013 Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-06-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-06-05 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be... on 2013-06-05. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but...". 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-1925-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-05
Posted: 2013-08-07
Terminated: 2015-03-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module.
Product code: JIT Calibrator, Secondary
Reason for recall: Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs, gel-like clumps may be observed.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated May 2013, to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed as follows: Until a permanent solution is identified, please follow the instructions listed in the letter in order to optimize calibration preparation; complete and return the attached Correction Effectiveness Check form via fax to the Siemens Technical Solutions Center at (302) 631-8467 and forward this notification to anyone to whom you may have distributed this product. If you have any questions, please contact the Siemens Technical Solutions Center or your local Siemens technical representative or call 800-441-9250.
Quantity in commerce: 7,470
Distribution: Nationwide distribution: US including states of : AK, AL, AR, AZ, CA, CO, CT, DC, GA, GU, FL, 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, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Product codes and lots: Product - MMB CAL, Catalog Number RC420, Siemens Material Number 10445023 with lot numbers 2GD053, 2KD024, and 3AD051.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1925-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1925-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-07

Product code JIT

K970336Class IIMmb CalibratorDade Chemistry Systems, Inc. / cleared 1997-03-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)