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U.S. Department of Health and Human Services

Class 2 Device Recall MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II

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 Class 2 Device Recall MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level IIsee related information
Date Initiated by FirmMay 19, 2022
Create DateJuly 06, 2022
Recall Status1 Terminated 3 on May 15, 2024
Recall NumberZ-1337-2022
Recall Event ID 90266
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
ProductMassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
Code Information Model: 0193; Lot Number: 2821; UDI/DI: 04250317502865
FEI Number 3003951180
Recalling Firm/
Manufacturer		 Chromsystems Instruments & Chemicals GmbH
Am Haag 12
Grafelfing Germany
For Additional Information Contactregulatory@chromsystems.com
+49 8918930 200
Manufacturer Reason
for Recall		Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
FDA Determined
Cause 2		Labeling Change Control
ActionThe firm issued a recall notification on 05/19/2022 via email. The notification mentions if the consignee has used the affected product, check whether they have determined glycine, replace the old package insert with the updated package insert with release date 18.05.2022, forward a copy of the letter to another laboratory if the affected product was given to them, and submit the response form by 01.06.2022. If users determined glycine, they are asked to clarify with the attending physician or laboratory director, if necessary, whether a back-check of the values for glycine is required.
Quantity in Commerce1457 units
DistributionUS: NY, OH, CT.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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