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Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits recallZ-1926-2017 · Magellan Diagnostics, Inc. · initiated Nov 29, 2014

Class I Terminated All recalls posted in May 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 Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.

FDA root cause category: Device Design

What the company is doing

Magellan issued a follow-on Recall notification related to the FDA Safety Notification dated May 17, 2017. This current recall follows FDAs recommendation to remove venous blood samples as an allowable sample type from all LeadCare products. This recall will supersede and replace the prior Recall notifications. Notifications issued by : UPS Letter (US), Registered Letter, E-mail, or Phone calls form May 23-May 25. Questions: Reba Daoust, Director of QA/RA 978-248-4811 or [email protected] Refer to Firm's website: http://www.leadcare2.com/getmedia/2fd8a90f-5c64-4058-b6ab-5db13512f0fe/Letter-to-our-customers-5-17-17.pdf.aspx. The notification of May 2017 supercedes the firms previous communications:. Magellan Diagnostics, notified customers by letter dated Nov 29, 2014 and provided with the problem, mitigation action( customers have been advised to implement a minimum 24-hour incubation of the blood-treatment reagent mixture prior to analysis) . Customers were instructed to return a completed FaxBack form via fax to 978-600-1480. A revised letter issued May 1, 2017 recommending that customers make the following workflow changes: 1. Discontinue collecting blood samples for lead testing in Becton Dickinson (BD) EDTA Vacutainer tubes: Lavender and Tan tops. 2. Discontinue the 24 hour incubation for sample preparation. On 5/17/17 FDA issued News Release - FDA warns Americans about risk of inaccurate results from certain lead tests- manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults. Blood drawn from a vein may provide results that are lower than the actual level in the blood. FDA is warning laboratories not to use Magellan Diagnostic lead tests wit blood drawn from the vein. At this time all Leadcare systems can be used with blood drawn from a finger or heel stick. Based on FDA/s warning the firm issued notification letter to users on 5/xx/17.

Recall details

Recall number
Z-1926-2017
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Nov 29, 2014
Posted by the FDA
May 18, 2017
Recalling firm
Magellan Diagnostics, Inc.
Quantity
1016
Product code
DOF
FDA submissions
K142705
Distribution
Nationwide Distribution

Product description

Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010

Code information (models, lots, serial numbers)

Kit lots: 1309BU,1310AU,1312BU,1404AU,1408BU

Other devices under the same FDA submission

1 device cleared under K142705 — 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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