Home / Recalls / Magellan Diagnostics, Inc. / Z-2226-2017

Z-2226-2017 Class I Terminated

Recalled by Magellan Diagnostics, Inc. — North Billerica, MA

FDA device recall Z-2226-2017 was initiated by Magellan Diagnostics, Inc. on May 23, 2017 and is designated Class I. Reason for recall: Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems The recall status is terminated (terminated July 8, 2021). Affected quantity: 6018 kits (total)= 5818 (US)and 200 (OUS).

Recall Details

Product Type
Devices
Report Date
June 14, 2017
Initiation Date
May 23, 2017
Termination Date
July 8, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6018 kits (total)= 5818 (US)and 200 (OUS)

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

All lot codes

Other recalls by Magellan Diagnostics, Inc.

  • Z-1895-2026 Class II — LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultr (March 13, 2026)
  • Z-1893-2026 Class II — (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (March 13, 2026)
  • Z-1894-2026 Class II — LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plu (March 13, 2026)
  • Z-0584-2026 Class II — The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique (February 23, 2024)
  • Z-0219-2024 Class II — LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit i (September 19, 2023)
  • Z-1953-2021 Class I — LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 (May 7, 2021)
  • Z-1954-2021 Class I — LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 (May 7, 2021)
  • Z-1952-2021 Class I — LeadCare II Blood Lead Test Kit Catalog Number 70-6762 (May 7, 2021)
  • Z-0285-2019 Class II — Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of (August 8, 2018)
  • Z-1295-2018 Class II — LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 7 (January 9, 2018)

FDA data resources