Immunoassay reaction vessels recalled over manufacturing deformities causing instrument errors
Beckman Coulter is recalling 38,225 Access 2 Reaction Vessels because certain lots may have a small protrusion or hair-like deformity that can cause instrument errors and delay patient results.
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: Scored 2 because the record's stated consequence is instrument errors that could delay results, with no erroneous results or reported harm.
Plain-English summary
Access 2 Reaction Vessels, catalog number 81901, are being recalled by Beckman Coulter, Inc. The vessels are individual disposable plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system.
Certain lots may contain manufacturing deformities: the bottom, round end of the reaction vessel may have a small protrusion or hair-like deformity. The firm states this could cause instrument errors, for example pipetting, rake or wash carousel errors, that could delay patient results.
The record lists 38,225 units carrying UDI-DI 15099590180249, across lots including P243943, P243971, P244202, P244344, P244345, P250001, P250002 and P250003. Distribution was nationwide in the United States and global. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is instrument errors that could delay patient results, and no injuries are reported. Laboratories should follow Beckman Coulter's instructions.
The recalled product
- Product
- Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 38,225
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 (9)
- UDI-DI: 15099590180249
- Lot Numbers: P243943
- P243971
- P244202 P244344
- P244345
- P250001
- P250002
- P250003
- P250004 and P250005
Distribution
Distributed nationwide across the United States.
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