FDA Medical Device Recalls (openFDA)
RANDOX LABORATORIES, LTD.: AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
- Recall number
- Z-2965-2020
- Recalling firm
- RANDOX LABORATORIES, LTD.
- Product
- AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
- Status
- Terminated
- Initiated
- 2020-07-30
- Posted
- not on file
- Terminated
- 2021-02-03
- Reason
- Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being observed on patient samples.
- Root cause
- Under Investigation by 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 technical.services@randox.com 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: customersupportusa@randox.com and PR at Tel: 1-787-701-7000 Email: Jose.Rosario@randox.com.
- Quantity
- 143 kits in total
- Distribution
- US Distribution to states of: VA, UT, WV and country of : Canada
- Lot, serial or model codes
- Catalogue Number: AM1015 GTIN: 05022273200256 Lot #: 517541 batch 517541
- 510(k) numbers
- ["K030873"]
- PMA numbers
- not on file
- Product code
- JIF
- Firm FEI
- 3006697287
- Firm city
- Crumlin Antrim
- Firm state
- Colorado
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28