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Magellan Diagnostics LeadCare Ultra and LeadCare Plus test… recallZ-2226-2017 · Magellan Diagnostics, Inc. · initiated May 23, 2017

Class I Terminated All recalls posted in June 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

Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems

FDA root cause category: Device Design

What the company is doing

Magellan issued a Safety Notification letter from May 23-25, 2017 . The firm states following the FDA Safety Notice, published May 17, 2017, this notification is to advise your facility regarding a change to existing LeadCare product usage and labeling. Prior instructions for use included capillary and venous blood samples. However, because the LeadCare Testing Systems may underestimate blood lead levels and give inaccurate results when processing venous blood samples, the FDA recommends discontinuing the use of venous blood samples with any LeadCare Blood Lead Testing System (LeadCare, LeadCare II, LeadCare Ultra, LeadCare Plus). Capillary samples may still be used on all LeadCare prducts listed above. Users requested to complete/sign Fax Form Record to verify that you have read and understood the Safety Communication to Customers on page 1. Contact Reba Daoust, Director of QA/RA 978-248-4811 or [email protected]

Recall details

Recall number
Z-2226-2017
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
May 23, 2017
Posted by the FDA
Jun 5, 2017
Recalling firm
Magellan Diagnostics, Inc.
Quantity
6018 kits (total)= 5818 (US)and 200 (OUS)
Product code
DOF
FDA submissions
K052549
Distribution
Worldwide Distribution - US (Nationwide) Foreign: AUSTRALIA AUSTRIA BOLIVIA CANADA CHILE CHINA COLOMBIA DOMINICAN REPUB ENGLAND GERMANY INDIA UK ISRAEL ITALY JAPAN KOREA MALI MYANMAR SPAIN NEPAL NETHERLANDS NEW ZEALAND P.R. CHINA PANAMA US PERU PHILLIPINES POLAND PORTUGAL REP OF KOSOVO SOUTH AFRICA SRI LANKA USA SWEDEN SWITZERLAND TRINIDAD UNITED ARAB EMI VIETNAM

Product description

Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.

Code information (models, lots, serial numbers)

All lot codes

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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