Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle Recalled by Medtest Holdings, Inc. Due to A Discrepancy was found on Hitachi AST (HA7...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtest Holdings, Inc. directly.
Affected Products
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.
Quantity: 119.168L across All lots
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtest Holdings, Inc.
Medtest Holdings, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report