FDA Recall
Terminated
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
Recall: Z-0969-2018
·
Initiated August 11, 2017
Recall
- Recall Number
- Z-0969-2018
- Event Number
- 79076
- Firm
- Randox Laboratories
- FEI Number
- 3003059701
- Product Code
- JJY
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 11, 2017
- Terminated
- March 29, 2019
- Address
- 515 Industrial Blvd, Kearneysville, WV, 25430-2778
Description
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
Reason
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
Action
On July 24, 2017 an Urgent notice was issued instructing customers to place a copy a notice in all kits remaining in stock. This notifies customers that they should amend the claims for open stability in the instructions for use, to state use immediately after the 30 minute reconstitution period. Questions or concerns can be emailed to [email protected]
Distribution
Distribution US nationwide.
Quantity
117 Kits