Chromsystems MassCheck Amino Acid Control: Low Glycine Risk
Chromsystems recalls MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I batch 2821 due to low glycine concentration. Affected units may not provide accurate blood testing results.
Lower-risk recall
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Contact the company
What happened, in plain English
Chromsystems is recalling a specific batch of dried blood spot controls because they contain too little glycine. This could lead to inaccurate blood test results if used in medical testing. Read more at govinfonow.com/recall/60689-chromsystems-masscheck-amino-acid-control-low-glycine-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/60689-chromsystems-masscheck-amino-acid-control-low-glycine-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1336-2022
Cite this page
“Chromsystems MassCheck Amino Acid Control: Low Glycine Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/60689-chromsystems-masscheck-amino-acid-control-low-glycine-risk. Based on FDA recall #Z-1336-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1336-2022%22&limit=1).
Why it’s dangerous
The dried blood controls have too low a glycine concentration, which can cause inaccurate blood test results. This means the test might not properly measure amino acids or acylcarnitines in blood samples.
Who’s affected
Users of the MassCheck Amino Acid, Acylc:arnitines Dried Blood Spot Control Level I batch 2821 are affected. Healthcare providers and labs using this product for blood testing may be at risk of inaccurate results.
How to tell if you have this one
Check for the model number 0192 and lot number 2821 on the product label. The product was sold by Chromsystems Instruments & Chemicals GmbH.
- Brand
Chromsystems- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US: NY, OH, CT.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1336-2022 | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I; Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841 | 1330 units |
| Z-1337-2022 | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II; Model: 0193; Lot Number: 2821; UDI/DI: 04250317502865 | 1457 units |
What to do — step by step
Check Product Details
Verify the model number (0192) and lot number (2821) on the product label.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “US: NY, OH, CT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Connecticut, New York, Ohio.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product dangerous?
No, this is a low-risk issue. The product may not provide accurate blood test results due to low glycine concentration, but it does not pose a direct safety hazard.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1336-2022 (May 19, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1336-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.