Device product

Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)

Z-0969-2018

August 11, 2017

Class III

Product summary

Firm: Randox Laboratories
Event: Event 79076
Status: Terminated
Classification: Class III
Quantity: 117 Kits
Official record key: device-enforcement:Z-0969-2018

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: IA2633 (Lots: 398703, 402366) IA2638 (Lot 1666EC) IA2639 (Lots: 1486EC, 1516EC, 1626EC) IA2640 (Lots 1517EC, 1668EC)

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.