Recall Z-0946-2015 ยท JIT Calibrator, Secondary
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
| Date | Jan 8, 2015 (initiated Nov 24, 2014) |
| Status | Terminated |
| Reason | Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed up to 12% at MYO concentrations within and above the reference range of the assay. Depending on quality control limits, this drift may not be detected. |
| Root cause | Under Investigation by firm |
| Action | The firm, Siemens, sent an "Urgent Medical Device Recall"letter dated November 2014, to all customers who received the affected lot. The letter described the product, problem and actions to be taken. The customers were instructed to: Review this letter with your Medical Director; discard your remaining inventory; recalibrate with an alternate in-date lot of MYO CAL, and complete and return the attached Field Correction Effectiveness Check Form and fax the form to (312) 275-7795. Siemens will replace any unused inventory of the affected lot at no charge. If you have any questions, please cont |
| Quantity | 1230 |
| Distribution | Worldwide Distribution: US (nationwide) and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053576 | DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR Dade Behring, Inc., Feb 7, 2006 |