Home / Recalls / Chromsystems Instruments & Chemicals GmbH / Z-1336-2022

Z-1336-2022 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
July 13, 2022
Initiation Date
May 19, 2022
Termination Date
May 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1330 units

Product Description

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

Reason for Recall

Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.

Distribution Pattern

US: NY, OH, CT.

Code Information

Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841

Other recalls by Chromsystems Instruments & Chemicals GmbH

  • Z-1337-2022 Class II — MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II (May 19, 2022)
  • Z-0536-2021 Class II — 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The ki (November 2, 2020)
  • 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-0521-2021 Class II — 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. (October 29, 2020)
  • Z-0522-2021 Class II — MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product U (October 29, 2020)
  • Z-0523-2021 Class II — MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product (October 29, 2020)