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U.S. Department of Health and Human Services

Class 2 Device Recall LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls

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 Class 2 Device Recall LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controlssee related information
Date Initiated by FirmJanuary 20, 2016
Date PostedAugust 15, 2017
Recall Status1 Terminated 3 on February 21, 2018
Recall NumberZ-3035-2017
Recall Event ID 77695
510(K)NumberK052549 
Product Classification Lead, atomic absorption - Product Code DOF
ProductLeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.
Code Information Lot # :1507N Exp Date: 1/27/17; Lot # :1508N Exp Date: 2/27/17; Lot # :1510N Exp Date: 4/19/17; Lot # :1511M Exp Date: 5/3/17 Lot # :1511N Exp Date: 5/17/17 Lot # :1512M Exp Date: 6/2/17
Recalling Firm/
Manufacturer		 Magellan Diagnostics, Inc.
101 Billerica Ave Bldg 4
North Billerica MA 01862-1271
For Additional Information ContactSAME
978-856-2339
Manufacturer Reason
for Recall		LeadCare II Test Kits controls out of range
FDA Determined
Cause 2		Device Design
ActionMagellan notified customers initially by Email, fax and/or verbal communication with Magellan Product Support representatives beginning on January 20, 2016 to advise of the problem and provide revised Assignment Control Value Matrix..
Quantity in Commerce12,931 kits
DistributionWorldwide - US Nationwide distribution and the countries of: COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DOF
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