The Recall Desk
ModerateFDA (Devices)·Z-1524-2015·Announced 2015-05-06

Beckman Coulter Recalls MicroScan Pos Combo 33 Panels Due to Missing Desiccants

Beckman Coulter is recalling 664 boxes of MicroScan Pos Combo 33 panels because some were packaged without desiccants, which may cause substrate deterioration.

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 hazard is limited to potential substrate deterioration due to moisture exposure, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Beckman Coulter, Inc. is recalling 664 boxes of MicroScan Pos Combo Panel Type 33 (PC33), catalog number B1017-211. These panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies of rapidly growing aerobic and facultative anaerobic gram-positive bacteria.

A Siemens investigation confirmed that a portion of one lot of these panels was packaged without desiccants. The substrates on a panel packaged without a desiccant may deteriorate over time due to exposure to additional moisture in the panel pouch.

The affected products were distributed nationwide, including Puerto Rico, and to the states of CT, GA, NC, OK, NY, SC, KY, TN, CA, WA, OR, NJ, OH, PA, FL, MI, TX, WI, MO, and NH. The specific lot number is 2014-09-12, with an expiration date of 2014-09-12. Siemens Material number (SMN) is 1071530. Users should stop using the affected panels and contact Beckman Coulter for instructions on return or replacement.

The recalled product

Product
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown o
Manufacturer
Beckman Coulter, Inc.
Category
Medical Device — Laboratory Diagnostic
Hazard
Affected units
664

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 B10170211
  • Siemens Material number (SMN): 1071530
  • lot number 2014-09-12.: Expiration date 2014-09-12.

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

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