Recall Z-0523-2021
Chromsystems Instruments & Chemicals GmbH · initiated October 29, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Order No. 0350, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)
Reason for recall
Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0523-2021
- Initiated
- October 29, 2020
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 850 vials
- Distribution
- US Nationwide distribution in the states of NC and NY.
- Recalling firm
- Chromsystems Instruments & Chemicals GmbH, Grafelfing
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0521-2021 Class II | 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 -…Calibrator lots may not meet stability criteria and could result in increased results of patient samples for… | 10/29/2020Completed |
| Z-0522-2021 Class II | MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage:…Control lots may not meet stability criteria and could result in increased results of patient samples for… | 10/29/2020Completed |