Liquid Assayed Specific Protein Control Level 3- In vitro… recallZ-0905-2023 · Randox Laboratories Ltd. · initiated Nov 22, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
FDA root cause category: Under Investigation by firm
What the company is doing
Randox Laboratories Ltd issued via email to the US Distributor Randox Laboratories-US, Ltd., Kearneysville, West Virginia on 11/22/22. The US Distributor contacted the customers by letter on 11/28/22. The Urgent Medical Device Correction letter states reason for recall, health risk and action to take: Discard previous IFUs and download the updated IFUs from randox.com 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. Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization.
Recall details
- Recall number
- Z-0905-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 22, 2022
- Posted by the FDA
- Jan 5, 2023
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 49 units US
- Product code
- JJY
- FDA submissions
- K972608
- Distribution
- US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
Product description
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
Code information (models, lots, serial numbers)
GTIN: 05055273204919 Lot Number/Exp. Date: 586LPC 28th Jun 23; 602LPC 28th Nov 23; 628LPC 28th Dec 24;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SP CONTROL 3 PS2684Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
Other devices under the same FDA submission
2 devices cleared under K972608 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SP CONTROL 1 PS2682Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- SP CONTROL 2 PS2683Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91225).
- Z-0903-2023 · Open, ClassifiedLiquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
- Z-0904-2023 · Open, ClassifiedLiquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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