Recall Z-2116-2017 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Medtest Holdings, Inc.
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
| Date | May 18, 2017 (initiated Feb 15, 2012) |
| Status | Terminated |
| Reason | A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert. |
| Root cause | Error in labeling |
| Action | Technical Bulletin Notification letter was sent 02/15/12 by email to all customers and distributors. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-757-5313. |
| Quantity | 119.168L across All lots |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941132 | LIQUID AST (SGOT)REAGENT SET Pointe Scientific, Inc.,, May 2, 1994 |