Reported May 24, 2017 · Terminated
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap.…
Medtest Holdings, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtest Holdings, Inc. · 5449 Research Dr · Canton, MI · 48188-2261
Is this the product you have?
- Pointe
- Scientific Hitachi AST Reagent R1PE plastic bottle w/PP plastic cap
- R2PE plastic bottle w /PP plastic cap
- Product UsageTwo Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers
- Lot codes and dates
- Catalog numbers
HA461HA761
- HA961 and lot codes
022204034801102401119503and 134101
- Catalog numbers
- Amount recalled
- 119.168L across All lots
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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