Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
- Company
- Randox Laboratories
- Recall Initiated
- August 11, 2017
- Terminated
- March 29, 2019
- Recall Number
- Z-0969-2018
- Quantity
- 117 Kits
- Firm Location
- Kearneysville, WV
Reason for Recall
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
Distribution
Distribution US nationwide.
Lot / Code Info
Catalog numbers: IA2633 (Lots: 398703, 402366) IA2638 (Lot 1666EC) IA2639 (Lots: 1486EC, 1516EC, 1626EC) IA2640 (Lots 1517EC, 1668EC)
Root Cause
Device Design
Action Taken
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 technical.services@randox.com
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