Reported Feb 1, 2017 · Terminated
Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement…
Sekisui Diagnostics P.E.I. Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sekisui Diagnostics P.E.I. Inc. · 70 Watts Ave · Charlottetown, N/A · N/A
Is this the product you have?
- Sekisui Diagnostics Ammonia L3K¿ Assay
- Catalog Number293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
- Lot codes and dates
- Catalog Number293-80-91
- Lot Numbers
4873748962490874922049258
- and Catalog Numbers293-10
- Lot Numbers
48967493304933149515
- Amount recalled
- 774 Liters bulk and 565 kits
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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