Rx series HbA1c recall
Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series…
Why was Rx series HbA1c recalled?
Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of the product.
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?
Lot/Batch 414553, expiry 28th Jan 2019
- Product
- Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series…
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 90 kits
- Distribution
- Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam
- Recall date
- January 3, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)