Recall Z-2773-2015 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
Pointe Scientific, Inc.
Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.
| Date | Sep 16, 2015 (initiated Dec 12, 2014) |
| Status | Terminated |
| Reason | Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications. |
| Root cause | Process control |
| Action | On 12/12/2014, Field Correction Notice notifications were sent to the affected distributors via electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to Pointe Scientifics Technical Service Department at 1-800-757-5313. |
| Quantity | 93 kits |
| Distribution | Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K830556 | CREATININE Pointe Scientific, Inc.,, Mar 24, 1983 |