Agency classClass IIIOur severity:Low FDA (Devices)·Z-2116-2017·Announced 2017-05-24

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.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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.
Category: Medical Device — Laboratory Reagents
Hazard: mis-labeling

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.

Same manufacturer · Medtest Holdings, Inc.

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Same hazard · mis labeling