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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus vulgaris

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  Class 2 Device Recall Proteus vulgaris see related information
Date Initiated by Firm October 12, 2007
Date Posted December 29, 2007
Recall Status1 Terminated 3 on June 26, 2008
Recall Number Z-0456-2008
Recall Event ID 45442
510(K)Number K861022  
Product Classification Quality Control for Culture Media Kit - Product Code JTR
Product MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp 2008-9; MicroBiologics, St. Cloud, MN 56303.

(Proteus vulgaris, Kwik-Stick, Cat. No. 0691P)
Code Information Lot Number: 691295
Recalling Firm/
Manufacturer
Microbiologics Inc
217 Osseo Ave N
Saint Cloud MN 56303-4452
For Additional Information Contact
320-253-1640
Manufacturer Reason
for Recall
Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus vulgaris.
FDA Determined
Cause 2
Employee error
Action Consignees were initially notified of this recall by a telephone survey. An Urgent Product Recall letter was sent on 10/17/07 explaining the risk to patients. The firm sent replacements of the recalled product on 10/17/07 or 10/18/07, with request for acknowledgement of Recall Notification, and certification of disposal of incorrect product.
Quantity in Commerce 20
Distribution Worldwide Distribution - USA including states of OR, PA, NY, RI, GA, SC, IL, PR, CA, AZ, and NJ, and countries of Japan, France, Colombia, and Brazil.
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 = JTR and Original Applicant = MICRO-BIO-LOGICS
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