Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Reported: August 14, 2019 Initiated: June 10, 2019 #Z-2207-2019
Product Description
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Reason for Recall
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.
Details
- Recalling Firm
- Randox Laboratories, Limited
- Units Affected
- 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.
- Location
- Crumlin, N/A
Frequently Asked Questions
What product was recalled? ▼
Assayed Bovine Multi-Sera Level 1, Model No. AL1027. Recalled by Randox Laboratories, Limited. Units affected: 4 kits (US).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2019. Severity: Low. Recall number: Z-2207-2019.
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