Reported Jul 19, 2017 · Ongoing
Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE…
AMS Diagnostics, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: AMS Diagnostics, LLC · 1790 N Commerce Pkwy · Weston, FL · 33326-3204
Is this the product you have?
- Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module
- Product UsageCalibrations of ISE Model for integrated electrolyte system analysis
- Lot codes and dates
P/N 5409Lot No. 15251Exp. Date 09/2016
- Amount recalled
- 9 units
Where it was sold
Why it was recalled
Lot was not functioning properly and not exhibiting the correct physical properties.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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