—#118035

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.

FDA product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K970336
Affected lot / code info: Product - MMB CAL, Catalog Number RC420, Siemens Material Number 10445023 with lot numbers 2GD053, 2KD024, and 3AD051.

Why it was recalled

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 (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-06-05
Posted by FDA: 2013-08-07
Terminated: 2015-03-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118035. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.