Recall Z-2116-2017
Medtest Holdings, Inc. · initiated February 15, 2012
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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.
Codes / lots: Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.
Reason for recall
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.
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-2116-2017
- Initiated
- February 15, 2012
- Posted by FDA
- May 18, 2017
- Terminated
- June 2, 2017
- Product code
- CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot
- Quantity
- 119.168L across All lots
- Distribution
- US Nationwide Distribution
- Recalling firm
- Medtest Holdings, Inc., Canton, MI