Horiba Medical Recalls ABX PENTRA Calibrators Due to Updated Target Values
Horiba Medical is recalling ABX PENTRA calibrators and controls because target values for the Creatinine Rate Blank Method were updated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The issue is a data update rather than a physical defect or contamination, fitting the Moderate severity criteria.
Plain-English summary
Horiba Medical is recalling ABX PENTRA Multical, N Control, and P Control products. The recall involves 2,023 units distributed nationwide in the United States. The products are benchtop clinical chemistry analyzers and calibrators used for measuring absorbance and ion selective electrodes.
The recall is being issued because the Target Values for the Creatinine Rate Blank Method have been updated. This issue is specific to the Creatinine Rate Blank Method values reported on the ABX PENTRA 400 and PC200 Chemistry Analyzers. No other analyzers are affected by this update.
Customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 are advised to stop using the affected products and contact Horiba Medical for further instructions regarding the updated target values.
The recalled product
- Product
- ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator…
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Hazard
- Affected units
- 2,023
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)
- Model Numbers:Multical - A11A01652
- N Control - A11A01653
- P Control - A11A01654. Lot Numbers: MultiCal: 1204101 and 1304901
- N Control: 1300801
- MultiCal: 1304901 Expires on 07/15/15
- N Control: 1300801 Expires on 11/05/14
- P Control: 1300601 Expires on 11/05/14.
Distribution
Distributed nationwide across the United States.
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