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LeadCare II Blood Lead Test Kit, containing LeadCare II… recallZ-3035-2017 · Magellan Diagnostics, Inc. · initiated Jan 20, 2016

Class II Terminated All recalls posted in August 2017

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Magellan Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

LeadCare II Test Kits controls out of range

FDA root cause category: Device Design

What the company is doing

Magellan 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..

Recall details

Recall number
Z-3035-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 20, 2016
Posted by the FDA
Aug 15, 2017
Recalling firm
Magellan Diagnostics, Inc.
Quantity
12,931 kits
Product code
DOF
FDA submissions
K052549
Distribution
Worldwide - US Nationwide distribution and the countries of: COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA

Product description

LeadCare 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 (models, lots, serial numbers)

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

Other devices under the same FDA submission

5 devices cleared under K052549 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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