Medtest Holdings Recalls Pointe Scientific Hitachi AST Reagent Due to Labeling Discrepancy
Medtest Holdings is recalling Pointe Scientific Hitachi AST Reagent because the package insert contains inconsistent linearity values in different sections.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling discrepancy rather than a direct safety hazard.
Plain-English summary
Medtest Holdings, Inc. is recalling Pointe Scientific Hitachi AST Reagent, a two-part chemistry reagent used for the quantitative determination of Aspartate Aminotransferase (AST) in human serum on Hitachi analyzers. The recall involves 119.168L of product distributed nationwide in the United States. Affected catalog numbers include HA461, HA761, and HA961, with specific lot codes 022204, 034801, 102401, 119503, and 134101.
The recall was initiated due to a discrepancy found in the package insert for the HA761 product. The Limitations section indicates a linearity of 500 U/L, while the Performance section lists a linearity of 0-600 U/L. This inconsistency does not match the 510k submission package insert. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Healthcare facilities and laboratories that have purchased this product should stop using it and contact Medtest Holdings, Inc. for further instructions on return or replacement. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- 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.
- Manufacturer
- Medtest Holdings, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Catalog numbers: HA461
- HA761
- HA961 and lot codes:022204
- 034801
- 102401
- 119503
- and 134101.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medtest Holdings, Inc.
See all →- LowMedtest AutoHDL/LDL Cholesterol Calibrator Recalled for Missing Vial Labels
FDA (Devices) · 2018-11-14
- LowMedtest Liquid Creatine Kinase Reagent Set Recalled for Labeling Mismatch
FDA (Devices) · 2017-07-05
- LowMedtest CRP Calibrator and Standard Sets Recalled for Unit Mislabeling
FDA (Devices) · 2017-07-05
- LowMedtest Holdings Recalls CK-MB Control Kits Due to Labeling Error
FDA (Devices) · 2017-07-05
- ModerateMedtest Recalls Pointe Scientific Hitachi Total Bilirubin R1 Reagent
FDA (Devices) · 2017-06-21
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02