Recall Z-2165-2017 ยท CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Medtest Holdings, Inc.
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
| Date | May 26, 2017 (initiated Jul 8, 2011) |
| Status | Terminated |
| Reason | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met. |
| Root cause | Nonconforming Material/Component |
| Action | Pointe Scientific issued field communication alerting end users of the corrected stability claim. To date the firm has sent individualized communications to 100% of end users that received the product and posted the notification to the company website. |
| Quantity | 716.146L total |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973589 | LIQUID LDH-L REAGENT SET Pointe Scientific, Inc.,, Oct 8, 1997 |