Home / Recalls / Chromsystems Instruments & Chemicals GmbH / Z-0522-2021

Z-0522-2021 Class II

Recalled by Chromsystems Instruments & Chemicals GmbH — Grafelfing, N/A

Recall Details

Product Type
Devices
Report Date
December 9, 2020
Initiation Date
October 29, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
880 vials

Product Description

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.

Reason for Recall

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

Distribution Pattern

US Nationwide distribution in the states of NC and NY.

Code Information

Order No. 0349, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)

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  • Z-0537-2021 Class II — MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product U (November 2, 2020)
  • Z-0539-2021 Class II — MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product (November 2, 2020)
  • Z-0538-2021 Class II — MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product (November 2, 2020)
  • Z-0536-2021 Class II — 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The ki (November 2, 2020)
  • Z-0521-2021 Class II — 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. (October 29, 2020)
  • Z-0523-2021 Class II — MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product (October 29, 2020)