Beckman Coulter Recalls MicroScan Neg Breakpoint Combo Panel Type 34
Beckman Coulter is recalling 681 boxes of MicroScan Neg Breakpoint Combo Panel Type 34 due to reported panel degradation.
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, only complaints of panel degradation. This aligns with a moderate severity for a medical device defect without reported harm.
Plain-English summary
Beckman Coulter, Inc. is recalling 681 boxes of the MicroScan Neg Breakpoint Combo Panel Type 34 (Catalog number B1017-404). The affected lot number is 2014-05-28, with an expiry date of 2014-05-28. The product is designed for determining antimicrobial agent susceptibility and identification of rapidly growing aerobic and facultative anaerobic gram-positive bacteria.
The recall was initiated after Siemens Healthcare Diagnostics received complaints regarding panel degradation in a portion of the affected lot. The product was distributed worldwide, including nationwide distribution in the United States (including Puerto Rico and specific states) and to Canada, Kuwait, South Africa, and Turkey.
Users of this product should stop using the affected lot and contact Beckman Coulter, Inc. for further instructions or a replacement.
The recalled product
- Product
- MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of…
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- Affected units
- 681
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)
- Catalog Number B1017-404
- lot # 2014-05-28
- Expiry 2014-05-28.
Distribution
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