Recall Z-2207-2019— Randox Laboratories, Limited
Class III · Terminated
Class III FDA medical device recall by Randox Laboratories, Limited, initiated 2019-06-10, terminated 2020-06-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Assayed Bovine Multi-Sera Level 1, Model No. AL1027. Reason: 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..
- Recalling firm
- Randox Laboratories, Limited
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-06-10
- Terminated
- 2020-06-16
- Firm location
- Crumlin, N/A, United Kingdom
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.