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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 vulgarissee related information
Date Initiated by FirmOctober 12, 2007
Date PostedDecember 29, 2007
Recall Status1 Terminated 3 on June 26, 2008
Recall NumberZ-0456-2008
Recall Event ID 45442
510(K)NumberK861022 
Product Classification Quality Control for Culture Media Kit - Product Code JTR
ProductMicroBiologics; 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
FEI Number 2150138
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
ActionConsignees 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 Commerce20
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = JTR
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