The Randox Serology I Positive Control contains the recall
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc…
Why was The Randox Serology I Positive Control contains the recalled?
***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactive) for Marker HBsAg resulting in delay in reporting patient results due to the positive control O36SR testing negative (Non-Reactive) for Marker HBsAg
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 05055273216509 Lot number: 036SR Exp Date: 28th March 2023
- Product
- The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc…
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the states of WV, NC.
- Recall date
- September 28, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)