Randox Laboratories recalls Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
- Recall date
- August 11, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0970-2018
- FDA classification
- Class III
- Brand / firm
- Randox Laboratories
- Sold / distributed
- Distribution US nationwide.
Why it was recalled
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
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