Recall Z-0970-2018
Randox Laboratories · initiated August 11, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
Codes / lots: Catalog numbers: IA3109 (Lots: 1476EC, 1573EC, 1619EC) IA3110 (Lots 1477EDC, 1599EDC, 1621EC, 1662EC) IA3111 (Lots: 1478EC, 1508EC, 1578EC, 1647EC) IA3112 (Lots: 359199, 377412, 373302, 382147, 382679, 395668, 416979)
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.
FDA-determined 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
Details
- Recall number
- Z-0970-2018
- Initiated
- August 11, 2017
- Terminated
- March 29, 2019
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 199 Kits
- Distribution
- Distribution US nationwide.
- Recalling firm
- Randox Laboratories, Kearneysville, WV
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0969-2018 Class III | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted… | 08/11/2017Terminated |