Recall Z-0988-2013 ยท JIT Calibrator, Secondary
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
| Date | Mar 25, 2013 (initiated Oct 10, 2012) |
| Status | Terminated |
| Reason | Correlation slope bias and accuracy shift |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent a Urgent Medical Device Correction letter dated October 16, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to calibrate with newer lots of Dimension Vista(R) ALP Calibrator as they become available, beginning with lot 2GD011. Customers were also asked to discontinue use and discard any remaining inventory of lot 2AD052. Customers further instructed to complete the attached response form and fax to (302) 631-8467, to indicate they had received the information and to |
| Quantity | 1985 cartons |
| Distribution | Nationwide distribution: USA including Puerto Rico and the states of AL, OH, MO, GA, IL, CT, IA, SC, VA, TX, FL, NY, NC, CA, NM, AZ, CA, MI, NJ, PR, MS, NE, WV, PA, MT, MA, MD, KS, NH, TN, VT, LA, CO, ID, WA, NH, DE and OR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061818 | DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) Dade Behring, Inc., Jul 18, 2006 |