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U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan Pos Combo Panel Type 33

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  Class 2 Device Recall MicroScan Pos Combo Panel Type 33 see related information
Date Initiated by Firm April 08, 2014
Date Posted April 27, 2015
Recall Status1 Terminated 3 on April 27, 2015
Recall Number Z-1524-2015
Recall Event ID 70904
510(K)Number K870074  
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
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.
Code Information Catalog number B10170211; Siemens Material number (SMN): 1071530, lot number 2014-09-12.: Expiration date 2014-09-12.
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
2040 Enterprise Blvd
West Sacramento CA 95691-3427
For Additional Information Contact Jose Untalan
916-374-3031
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action Siemens sent an Urgent Medical Device Recall letter dated April 8, 2014, to all affected customers. Letters advised users of the recalled product with catalog number, Siemens Material Number and Lot number as well as the reason for recall. The risk to health was explained as well as the recommendation for discussing the content of the letter with the medical director regarding the need to review previous test results. Customers are asked to discontinue use and discard any remaining inventory of the PC33 panel 2014-09-12. All other lot numbers are not impacted. The attached confirmation receipt is to be completed and returned and the letter should remain with laboratory records. Questions should be directed to Siemens Customer Care Center. For further questions call (916) 374-3031.
Quantity in Commerce 664 panel boxes
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JWY and Original Applicant = MICROSCAN DIV. BAXTER HEALTHCARE CORP.
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