Device product

Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)

Z-0970-2018

August 11, 2017

Class III

Product summary

Firm: Randox Laboratories
Event: Event 79076
Status: Terminated
Classification: Class III
Quantity: 199 Kits
Official record key: device-enforcement:Z-0970-2018

Official wording

Reason: The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.

Code information: 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)

Distribution pattern: Distribution US nationwide.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.