Beckman Coulter Access PCT Reagent Pack Recalled for Calibration Failures
Beckman Coulter Inc. is recalling specific lots of Access PCT Reagent Pack due to high rates of calibration failures that delay test result reporting on immunoassay systems used in healthcare and laboratory settings.
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: FDA Class II device with an operational reliability issue. No hospitalizations, injuries, or illnesses reported. The hazard is an immediate and apparent calibration failure, not a hidden health threat. Delayed test result reporting is a consequence of the device malfunction, not a direct patient safety hazard.
Plain-English summary
Beckman Coulter Inc. is recalling specific lots of the Access PCT Reagent Pack (Catalog Number C53987), which is used with Access 2 and UniCel DxI immunoassay systems in healthcare and laboratory settings.
The affected reagent lots (339062 and 439811) are experiencing a high rate of calibration failures on the immunoassay systems, generating a "Max Iterate" error code. These failures prevent the systems from completing their calibration process, which delays the reporting of test results.
The recalled product has been distributed worldwide, with 6,994 units in the US and 10,067 units distributed to more than 35 other countries.
The recalled product
- Product
- Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
- Manufacturer
- Beckman Coulter Inc.
- Category
- Medical Device
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)
- UDI-DI 15099590736002 Lots 339062
- 439811
Distribution
Distributed nationwide across the United States.
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