FDAClass IIIAugust 14, 2019

Assayed Bovine Multi-Sera Level 1 recall

Assayed Bovine Multi-Sera Level 1, Model No. AL1027

Why was Assayed Bovine Multi-Sera Level 1 recalled?

The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.

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?

205SL

Product
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Recalling firm
Randox Laboratories, Limited
Quantity
4 kits (US)
Distribution
Domestic distribution to Arizona, Oregon, Washington, and West Virginia. Foreign distribution to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and UK.
Recall date
August 14, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
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