Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in
FDA device recall Z-1925-2013 · posted 2013-08-07 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- JIT
- Quantity affected
- 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
- Date initiated
- 2013-06-05
- Date posted
- 2013-08-07
- Date terminated
- 2015-03-18
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MMB CALIBRATOR (K970336) | Dade Chemistry Systems, Inc. | 1997-03-03 |