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U.S. Department of Health and Human Services

Class 2 Device Recall Blood Agar (TSA with 5 Sheep Blood)

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 Class 2 Device Recall Blood Agar (TSA with 5 Sheep Blood)see related information
Date Initiated by FirmMarch 24, 2017
Date PostedApril 27, 2017
Recall Status1 Terminated 3 on June 06, 2017
Recall NumberZ-1888-2017
Recall Event ID 76846
Product Classification Culture media, non-selective and differential - Product Code JSH
ProductBlood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.
Code Information 101686
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactGary Klaassen
913-895-4077
Manufacturer Reason
for Recall		Confirmed complaint of surface contamination of Listeria monocytogenes.
FDA Determined
Cause 2		Material/Component Contamination
ActionOn 3/24/2017, the recalling firm sent a recall notice to their customers explaining the reason for the recall and instructing customers to review their stock and discard any affected product. The notice also instructed customers to advise of the recall anyone they may have further distributed the recalled lot to. Attached to the recall notice is a response form which the recalling firm instructed their consignees to fill out and return.
Quantity in Commerce1,159/100 plates/packs
DistributionUS Nationwide distribution in the states of : AR, AZ, CO, IA, IL, KS, KY, LA, MI, MO, MS, MT, NC, ND, NE, NM, OH, OK, SD, and TX and Puerto Rico
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.
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