Recall Z-1543-06 ยท JIX Calibrator, Multi-Analyte Mixture
Pointe Scientific, Inc.
Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufactured for Pointe Scientific, Inc.; Catalog number A7504-CTL.
| Date | Sep 30, 2006 (initiated Jun 9, 2006) |
| Status | Terminated |
| Reason | Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability. |
| Root cause | Other |
| Action | Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. |
| Quantity | 44 units |
| Distribution | Worldwide distribution ---- including USA and countries of Canada, Ecuador, Germany, Greece, India, Mexico, Peru, Poland, Portugal, Trinidad, United Arab Emirates and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972333 | AMMONIA/IRON STANDARD KIT Verichem Laboratories, Inc., Jul 23, 1997 |