|
Class 2 Device Recall PREMIER EHEC and PREMIER EHEC Bulk |
|
Date Initiated by Firm |
November 08, 2016 |
Date Posted |
January 17, 2017 |
Recall Status1 |
Terminated 3 on August 16, 2017 |
Recall Number |
Z-1033-2017 |
Recall Event ID |
75651 |
510(K)Number |
K953362
|
Product Classification |
Antisera, all types, escherichia coli - Product Code GNA
|
Product |
PREMIER EHEC and PREMIER EHEC Bulk. |
Code Information |
PREMIER EHEC Product Code 608096: Lot # 608096H219, Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.138 Exp Date 9/30/2017; Lot # 608096H222, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.14 Exp Date 1/12/2018; Lot # 608096H224, Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.141 Exp Date 1/29/2018; Lot # 608096H225, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.142, Exp Date 2/5/2018 & Lot # 608096H226, Exp Date 3/6/2018, Detection Antibody Reagent, Lot # 8603.143, Exp Date 3/22/2018. PREMIER EHEC Bulk Product Code 608096BU: Lot # 608096H220 Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.138, Exp Date 9/30/2017; Lot #, 608096H223, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.14, Exp Date 1/12/2018 & Lot # 608096H227, Exp Date 3/6/2018, Detection Antibody Reagent, Lot # 8603.143, Exp Date 3/22/2018. |
Recalling Firm/ Manufacturer |
Meridian Bioscience Inc 3471 River Hills Dr Cincinnati OH 45244-3023
|
For Additional Information Contact |
Chris M. Ross 800-343-3858
|
Manufacturer Reason for Recall |
Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
On November 7, 2016 the firm sent Voluntary Medical Device Recall Letters and reply forms to their customers. |
Quantity in Commerce |
4,747 EHEC + 180 EHEC Bulk |
Distribution |
Product was shipped to the following states: AL. AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY.
Product was also sent to the following countries: CANADA, GERMANY, HONG KONG, ITALY, JAPAN & NEW ZEALAND. |
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 = GNA and Original Applicant = MERIDIAN DIAGNOSTICS, INC.
|
|
|
|