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Recall Observatory FDA recall evidence

Device 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 on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria.

Z-1524-2015

April 08, 2014

Class II

Product summary

Firm
Beckman Coulter, Inc.
Event
Event 70904
Status
Terminated
Classification
Class II
Quantity
664 panel boxes
Official record key
device-enforcement:Z-1524-2015

Official wording

Reason: Siemens investigation confirmed that a portion one lot of panel Pos Combo 33 lot 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.

Code information: Catalog number B10170211; Siemens Material number (SMN): 1071530, lot number 2014-09-12.: Expiration date 2014-09-12.

Distribution pattern: Nationwide Distribution 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens investigation confirmed that a portion one lot of panel Pos Combo 33 lot 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.