Recall Z-0219-2024— Magellan Diagnostics, Inc.

Name: FDA recall Z-0219-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-19

Class II · Ongoing

Class II FDA medical device recall by Magellan Diagnostics, Inc., initiated 2023-09-19. It names one FDA 510(k) clearance: K052549. Product: LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.. Reason: During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation of treatment reagent. The consequence of this would be a change in the volume of treatment reagent and a change in the ratios of either added patient sample or control material to treatment reagent. The result of this might be a falsely elevated result (e.g., a patient false positive [PATFP] result or a Controls Out of Range-High [COOR-Hi] result)..

Recalling firm: Magellan Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-09-19
Firm location: North Billerica, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K052549 — LEADCARE II BLOOD LEAD TESTING SYSTEMEsa Biosciences, Inc.·cleared 2005-10-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.

Reason for recall

During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation of treatment reagent. The consequence of this would be a change in the volume of treatment reagent and a change in the ratios of either added patient sample or control material to treatment reagent. The result of this might be a falsely elevated result (e.g., a patient false positive [PATFP] result or a Controls Out of Range-High [COOR-Hi] result).

Data sourced from openFDA. This site is unofficial and independent of the FDA.