Medica ISE Module Calibrant A recall
Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage…
Why was Medica ISE Module Calibrant A recalled?
Lot was not functioning properly and not exhibiting the correct physical properties.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
P/N 5409; Lot No. 15251; Exp. Date 09/2016
- Product
- Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage…
- Recalling firm
- AMS Diagnostics, LLC
- Quantity
- 9 units
- Distribution
- US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.
- Recall date
- July 19, 2017
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)