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Recall Observatory FDA recall evidence

Device product

Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

Z-1078-2017

November 29, 2016

Class II

Product summary

Firm
Sekisui Diagnostics P.E.I. Inc.
Event
Event 75818
Status
Terminated
Classification
Class II
Quantity
774 Liters bulk and 565 kits
Official record key
device-enforcement:Z-1078-2017

Official wording

Reason: Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.

Code information: Catalog Number: 293-80-91; Lot Numbers: 48737, 48962, 49087, 49220, 49258 and Catalog Numbers: 293-10; Lot Numbers: 48967, 49330, 49331, 49515

Distribution pattern: Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.