Horiba Medical Recalls Pentra C200 Automated Chemistry Analyzer
Horiba Medical is recalling 384 Pentra C200 analyzers because they may record incorrect AST values without triggering an alarm.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Horiba Medical is recalling 384 units of the PENTRA C200 automated chemistry analyzer (Part Number: A11A01629). The recall is due to a defect identified during validation testing where the system recorded incorrect, lower values for Aspartate Aminotransferase (AST) without generating an alarm.
During the AST application validation using an Audit Systems linearity kit, the Pentra C200 recorded values of 280 U/L and 199 U/L for samples expected to measure 800 U/L and 1000 U/L, respectively. The device failed to issue an alarm for these discrepancies. The affected units were distributed nationwide, including in California, Oklahoma, New York, Florida, Arizona, Virginia, and Texas.
This recall is classified as Class II by the FDA. Healthcare facilities and laboratories using these analyzers should contact Horiba Medical for instructions on how to address the defect.
The recalled product
- Product
- PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and urin
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Affected units
- 384
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 (1)
- Lot number: 00456-4108
Distribution
Part of a larger recall action
This product is one of 2 recalled by Horiba Instruments, Inc dba Horiba Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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