FDAFDA · Food and drugs·Recall number Z-2116-2017
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.
Published May 24, 2017 · Recall initiated: February 15, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Medtest Holdings, Inc.
- Distributor
- US Nationwide Distribution
- Lot
- Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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