Recall Z-1043-2010 ยท CIC Cresolphthalein Complexone, Calcium
Pointe Scientific, Inc.
Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R2. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
| Date | Mar 10, 2010 (initiated Nov 10, 2009) |
| Status | Terminated |
| Reason | Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated. |
| Root cause | Process control |
| Action | Consignees were notified by "Urgent: Medical Device Recall" letter dated November 11, 2009 and instructed to conduct a recall to the retail level, that users should dispose of the product immediately, and that a business reply card should be returned to account for products. If you have any questions, please call Pointe Scientific, Inc. Technical Support Department at 1-800-757-5313 or 1-734-487-8300. |
| Quantity | 4 sets and 9 L |
| Distribution | Worldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822469 | PSI CALCIUM REAGENT Pointe Scientific, Inc.,, Sep 14, 1982 |