SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
FDA Recall Z-0660-2019 · Posted None
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Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeJIX
Date Initiated2018-11-19
Date Terminated2020-04-23
Product Quantity250 kits (32 kits US / 218 kits OUS)
Reason for Recall
Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
Firm Action
On November 19, 2018, Randox Laboratories Ltd. issued "Urgent Medical Device Correction" notices and New Calibrator Value sheets (Revised 15 Nov 18 pl) to customers.
Customers were advised to take the following action:
- Review all remaining stock. Add the notice and replace the calibrator value sheet with the revised document provided.
- Discuss the contents of the notice with your Medical Director. Review results generated with the affected batches in line with the clinical profile of the patient.
- Retain a copy of the letter with laboratory records and forward a copy of the letter to those who may have received this product.
- Return the completed response form via email to [email protected].
If you have any questions, contact RA Specialist by email at [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.
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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