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U.S. Department of Health and Human Services

Class 2 Device Recall Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum

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  Class 2 Device Recall Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum see related information
Date Initiated by Firm December 08, 2017
Create Date December 26, 2017
Recall Status1 Terminated 3 on July 22, 2020
Recall Number Z-0290-2018
Recall Event ID 78728
Product Classification Antisera, all types, shigella spp. - Product Code GNB
Product Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01.

Product Usage:
Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.
Code Information UDI 50560805009592. Kit lot #1465529, Bottle lot #1465528; Kit lot #2118879, Bottle lot #1847290; Kit lot #2173683, Bottle lot #1847290; Kit lot #2161363, Bottle lot #1847290; Kit lot #1984639, Bottle lot #1847290; Kit lot #1738564, Bottle lot#1738565; Kit lot #1971308, Bottle lot #1738565; Kit lot #1957305, Bottle lot #1738565; Kit lot #1947930, Bottle lot #1738565; and Kit lot #1847285, Bottle lot #1738565.
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Gary Klaassen
913-895-4077
Manufacturer Reason
for Recall		 The serum may fail to agglutinate within the specified minimum reaction time.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued letters dated 12/8/2017 via regular mail. The letter identified the affected product, problem and actions to be taken. The risk to health is also explained. The customer is requested to notify any personnel who need to be aware of the potential for incorrect performance specification for the product. The customer is to inspect their stock and destroy any remaining inventory of the lots listed. They are to contact Customer Service or their local distributor for replacement. A response form was to be returned acknowledging receipt of the notice and disposal of the affected product. If the product was further distributed, the customer was requested to contact their downstream customers, advise them of the recall, and provide them a copy of the recall letter.
Quantity in Commerce 237 units (single bottles)
Distribution US 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.
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