The Recall Desk
ModerateFDA (Devices)·Z-1522-2015·Announced 2015-05-06

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.

What this means for you

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 co
Manufacturer
Beckman Coulter, Inc.
Category
Medical Device — Laboratory Diagnostic
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

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Related recalls

Same manufacturer · Beckman Coulter, Inc.

See all →