MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Summary
The FDA issued a Class II for MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I by Chromsystems Instruments & Chemicals GmbH. Reason: Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products..
Details
Source
Device Recall
External ID
Z-1336-2022
Action Date
2022-07-13
Status
Terminated
Category
device
Product Description
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Lot/Code Info: Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841
Quantity Affected: 1330 units
Reason for Recall
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Distribution
US: NY, OH, CT.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-19
Company
Grafelfing, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 120 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Chromsystems Instruments & Chemicals GmbH has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Chromsystems Instruments & Chemicals GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Chromsystems Instruments & Chemicals GmbH have FDA actions?
Chromsystems Instruments & Chemicals GmbH has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1336-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29