FDAClass IIApril 3, 2019

Randox Blood Gas Control Level 2 -Model BG5002. recall

Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro…

Why was Randox Blood Gas Control Level 2 -Model BG5002. recalled?

An error in the assignment of the control range pH in Blood Gas Control

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 Code: 184BG GTIN: 05055273227116

Product
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro…
Recalling firm
Randox Laboratories Ltd.
Quantity
1 kit
Distribution
US Distribution to state of: WV
Recall date
April 3, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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