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U.S. Department of Health and Human Services

Class 2 Device Recall PF4 Concentrated Wash

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  Class 2 Device Recall PF4 Concentrated Wash see related information
Date Initiated by Firm December 15, 2014
Date Posted January 20, 2015
Recall Status1 Terminated 3 on April 30, 2015
Recall Number Z-1001-2015
Recall Event ID 70012
510(K)Number K053559  
Product Classification Platelet factor 4 radioimmunoassay - Product Code LCO
Product PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and
2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45)

The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The
PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react
with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic
compounds. The PF4 IgG kit contains all of the reagents necessary to perform
the assay.
Code Information Reagent Lot Numbers: 3001620, 3001987, 3002083, 3002153
Recalling Firm/
Manufacturer		 Genetic Testing Institute,inc
20925 Crossroads Cir Ste 200
Waukesha WI 53186-4054
For Additional Information Contact Technical Support
262-754-1000
Manufacturer Reason
for Recall		 Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.
FDA Determined
Cause 2		 Employee error
Action Immucor sent an Urgent - Field Safety Notice letter dated December 15, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to stop using the recalled product and to destroy it. Requested consignees to complete the Customer Response From and return to waukeshatechsupport@immucor.com. Please contact Technical Support should you need additional information at 262.754.1000 or waukeshatechsupport@immucor.com.
Quantity in Commerce 6206 kits
Distribution Worldwide Distribution - Nationwide Distribution to the states of : AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN,TX, UT, VA, WA, WV and WI., and the countries of : Canada, Japan, Belgium, European Union , Australia, Taiwan, Thailand and Scotland. ( some countries not yet identified )
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 = LCO and Original Applicant = GENETIC TESTING INSTITUTE
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