AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Recall Z-2966-2020 · Posted None
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Recalling FirmRANDOX LABORATORIES, LTD.
Recall StatusTerminated
Product CodeJIF
Date Initiated2020-07-30
Date Terminated2021-02-03
Product Quantity143 kits in total
Reason for Recall
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being observed on patient samples.
Firm Action
The firm, Randox Laboratories Ltd., sent an "Urgent Medical Device Correction" letter dated 30th July 2020 to it customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
- Discontinue use of, quarantine and discard any stock of AM1015, batch 517541 and AM1054, batch 512103 immediately.
- Review results generated with the affected batches in line with the clinical profile of the patient.
- Discuss the contents of this notice with your Medical Director.
-Review your reagent inventory of these products and assess your laboratory needs for reimbursement for discarded inventory.
-Complete and return the response form 12187-QA to [email protected] within five working days.
If you have any questions or concerns please contact Randox Technical Services. Local at Tel: +1 304 728 2890 Toll Free 866 4 RANDOX Email: [email protected] and PR at Tel: 1-787-701-7000
Email: [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
US Distribution to states of: VA, UT, WV and country of : Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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