Recall Z-0676-06 ยท JIX Calibrator, Multi-Analyte Mixture
Alfa Wassermann, Inc
Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.
| Date | Mar 23, 2006 (initiated Jan 26, 2006) |
| Status | Terminated |
| Reason | Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high. |
| Root cause | Other |
| Action | Field correction letters were sent to the firm's customers via FAX on 1/14/2006-1/17/2006 and via UPS on 1/17/2006-1/19/2006. An updated letter was sent out via FAX on 1/27,30,31/2006 and via UPS on 1/30/2006 and 2/1/2006. |
| Quantity | 22,987 kits |
| Distribution | The kits were sent nationwide. The product was shipped to Alfa Wasserman's sister firm in Wergen, Netherlands. There are several US Navy accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930104 | ACE CLINICAL CHEMISTRY SYSTEM Schiapparelli Biosystems, Inc., Aug 23, 1993 |