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U.S. Department of Health and Human Services

Class 2 Device Recall MicroVue BAP EIA, Model 8012

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  Class 2 Device Recall MicroVue BAP EIA, Model 8012 see related information
Date Initiated by Firm July 14, 2016
Create Date May 10, 2018
Recall Status1 Terminated 3 on August 28, 2020
Recall Number Z-1797-2018
Recall Event ID 79621
510(K)Number K981373  
Product Classification Electrophoretic separation, alkaline phosphatase isoenzymes - Product Code CIN
Product MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
Code Information Lot 067850
Recalling Firm/
Manufacturer		 Diagnostic Hybrids, Inc.
2005 E State St Ste 100
Athens OH 45701-2125
For Additional Information Contact Ronald H. Lollar
740-589-3373
Manufacturer Reason
for Recall		 There is a possibility of low volume and/or leaking standard bottles.
FDA Determined
Cause 2		 Process control
Action Customers were contacted via telephone and a letter dated 7/14/16. The letter instructed customers to review their inventory for the specified lot number, check for any low-volume or leaking standards, and contact the recalling firm if necessary.
Quantity in Commerce 1004
Distribution The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI. The products were distributed to the following foreign countries: Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Switzerland, and Uruguay.
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 = CIN and Original Applicant = METRA BIOSYSTEMS, INC.
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