MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Recall Z-0522-2021 · Posted None
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Recalling FirmChromsystems Instruments & Chemicals GmbH
Recall StatusCompleted
Product CodeJJY
Date Initiated2020-10-29
Product Quantity880 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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