Recall Z-1184-2018 ยท JIX Calibrator, Multi-Analyte Mixture
Siemens Healthcare Diagnostics, Inc.
Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.
| Date | Mar 26, 2018 (initiated Nov 9, 2017) |
| Status | Terminated |
| Reason | An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay. |
| Root cause | Under Investigation by firm |
| Action | The firm, Siemens, issued an "Urgent Medical Device Correction (VC18-01.A.US)" letter dated 11/3/2017, to US customers on November 3, 2017 and an "Urgent Field Safety Notice (VC18-01.A.OUS)" to customers outside the US in November 2017. Customers were instructed to: " Discontinue use of and discard impacted LOCI 8 CAL lot 7CD076 " Calibrate the E2 assay using an alternate lot of LOCI 8 CAL. " Review the letter with their Medical Director. " Review their inventory of this product to determine theirs laboratory's replacement needs and to provide information to Siemens for reporting to the reg |
| Quantity | 989 (681 USA/308 OUS) |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101460 | LOCI 8 CALIBRATOR, MODEL KC 646 Siemens Healthcare Diagnostics, Jul 9, 2010 |