Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Remel Blood Agar, 5 Sheep Blood REF R01202

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Remel Blood Agar, 5 Sheep Blood REF R01202 see related information
Date Initiated by Firm May 04, 2015
Date Posted June 10, 2015
Recall Status1 Terminated 3 on February 13, 2017
Recall Number Z-1748-2015
Recall Event ID 71198
Product Classification Culture media, non-selective and non-differential - Product Code JSG
Product Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates).

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 Lot Number: 646595 and 646596 Expiration date: 19May2015
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Scott A. Kendall
770-409-0713
Manufacturer Reason
for Recall		 Product may be contaminated with Listeria monocytogenes.
FDA Determined
Cause 2		 Material/Component Contamination
Action The recalling firm sent the recall notification letter (dated May 1, 2015) to all customers on 5/4/2015 via standard mail.
Quantity in Commerce 845/10/10-plate pack cases
Distribution Nationwide Distribution.
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.
-
-