Beckman Coulter Recalls MicroScan MICroSTREP Plus Panel Due to QC Failures
Beckman Coulter is recalling 523 boxes of MicroScan MICroSTREP Plus Panel and associated broth due to quality control testing failures.
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling 523 boxes of MicroScan MICroSTREP Plus Panel and MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015. The affected product is identified by Lot Number 1005986140 and has an expiration date of April 1, 2018.
The recall was initiated after the company received customer complaints regarding lowered minimum inhibitory concentration (MIC) results for the antimicrobial agents Cefaclor and Penicillin. These issues were observed during quality control testing using the control organism Streptococcus pneumoniae (ATCC 49619) on MICroSTREP plus Panel Type 1.
The product was distributed nationwide in the United States and internationally to Canada, Kuwait, South Korea, and Saudi Arabia. The MicroScan MICroSTREP plus panels are designed for determining antimicrobial agent susceptibility of aerobic streptococci. Users should stop using the affected lots and contact Beckman Coulter for further instructions.
The recalled product
- Product
- BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroScan MICroSTREP plus and MicroFAST panels. MICroSTREP plus…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 523
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 (3)
- Lot Number 1005986140
- Expiration date April 1
- 2018
Distribution
Distributed nationwide across the United States.
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