Randox Blood Gas Control Level 2 -Model BG5002 recallZ-1057-2019 · Randox Laboratories Ltd. · initiated Feb 13, 2019
Terminated
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
An error in the assignment of the control range pH in Blood Gas Control
FDA root cause category: Process control
What the company is doing
The firm, Randox Laboratories Ltd, sent an "Urgent Medical Device Correction " letter dated 2/13/2019 to its customer on 2/13/2019 via email. The letter describes the product, problem and actions to be taken. The customer was instructed todo the following: " Please replace the amended value sheet within the kit of any remaining stock. " Discuss the contents of this notice with your Medical Director. " Randox Laboratories Ltd is not recommending a review of previous results as any issue would be observed at the time of use. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " 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 by email at [email protected], or telephone +44 (0)28 9442 2413 or Email: [email protected].
Recall details
- Recall number
- Z-1057-2019
- Status
- Terminated
- Initiated by the company
- Feb 13, 2019
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 1 kit
- Product code
- JJY
- FDA submissions
- K093384
- Distribution
- US Distribution to state of: WV
Product description
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
Code information (models, lots, serial numbers)
Lot Code: 184BG GTIN: 05055273227116
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BLOOD GAS CONTROL - LEVEL 2 (BG CONTROL 2) BG5002Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
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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