Recall Z-0104-2010 ยท CFR Hexokinase, Glucose
Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and 7-G7517-1000. (Clinical chemistry) Pointe Scientific Liquid Glucose (HEXO) is used for the quantitative determination of glucose in serum.
| Date | Nov 4, 2009 (initiated Oct 19, 2009) |
| Status | Terminated |
| Reason | There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL. |
| Root cause | Process design |
| Action | The firm issued a press release, and an amended press release, on 10/30/09. Consignees were notified by an Urgent: Medical Device Recall letter dated 10/19/09, which identified the problem; and, instructed testing laboratories to inform patients' attending physicians, and determine, with their input, whether confirmation of the previous test results will be required. Customers are to examine their inventory for any of the lot numbers listed on the letter; and, for any product that has been further distributed, those customers need to be identified and notified of this product recall by inclu |
| Quantity | 400 kits plus 59 liters and 15 vials. |
| Distribution | Worldwide Distribution -- USA, Israel, Mexico, South Africa, and West Indies. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971754 | LIQUID GLUCOSE (HEXOKINASE) REAGENT SET Pointe Scientific, Inc.,, Jul 22, 1997 |