Horiba Medical Recalls ABX PENTRA Urine Control L/H for Creatinine Range Update
Horiba Medical is recalling ABX PENTRA Urine Control L/H because the target range for the Creatinine assay was updated. The recall affects 531 units distributed in the US and Canada.
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: This is an FDA Class III recall involving a documentation update to quality control target ranges, which is unlikely to cause adverse health consequences.
Plain-English summary
Horiba Medical is recalling 531 units of ABX PENTRA Urine Control L/H, a quality control product used for monitoring accuracy and precision on ABX PENTRA chemistry analyzers. The product consists of liquid solutions prepared from human urine with chemical additives.
The recall is being conducted because the Target Range for the Creatinine assay has been updated. Horiba Medical has updated the lot-specific annexes to include the revised acceptable Target Ranges for Creatinine. No other analyte values are affected by this change.
The affected units are distributed nationwide in the United States and in Canada. The specific lots involved are 1207001, 1303601, and 1300701. Customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers should check their lot-specific annexes for the updated ranges.
The recalled product
- Product
- ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component…
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Hazard
- Affected units
- 531
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 (2)
- Model/Part #(s): A11A01674. Lot/Serial #(s): 1207001
- 1303601
Distribution
Distributed nationwide across the United States.
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