Home / Recalls / Chromsystems Instruments & Chemicals GmbH / Z-1337-2022

Z-1337-2022 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
1457 units

Product Description

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II

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: 0193; Lot Number: 2821; UDI/DI: 04250317502865

Other recalls by Chromsystems Instruments & Chemicals GmbH

  • Z-1336-2022 Class II — MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I (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-0523-2021 Class II — MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product (October 29, 2020)
  • Z-0522-2021 Class II — MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product U (October 29, 2020)
  • Z-0521-2021 Class II — 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. (October 29, 2020)