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Completed

MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

FDA Recall Z-0523-2021 · Posted None

Recall StatusCompleted
Product CodeJJY
Date Initiated2020-10-29
Product Quantity850 vials

Reason for Recall

Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

Firm Action

The firm sent consignees a recall notification letter dated 10/28/2020. Consignees are asked to stop using products and to destroy remaining stock of affected product in accordance with the consignees laboratory procedures. The recalling firm will replace affected stock with new lots. Consignees are asked to further disseminate recall information to any other customers that the product has been shipped to. A response form is included with the recall notification letter and customers are asked to complete the form and return to the recalling firm.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of NC and NY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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