Recall Z-0523-2021 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Chromsystems Instruments & Chemicals GmbH
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.
| Date | Oct 29, 2020 |
| Status | Completed |
| Reason | Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone. |
| Root cause | Under Investigation by 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. |
| Quantity | 850 vials |
| Distribution | US Nationwide distribution in the states of NC and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.