Reported Dec 16, 2020 · Terminated
3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic…
Chromsystems Instruments & Chemicals GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Chromsystems Instruments & Chemicals GmbH · Am Haag 12 · Grafelfing, N/A · N/A
Is this the product you have?
3PLUS1 Multilevel Plasma Calibrator SetOrder No. 75128 -
- Product UsageThe kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder
- Lot codes and dates
- Order No. 75128, Lots No. 2219 (expiration 05/01/2022) and 2320 (expiration 06/01/2023)
- Amount recalled
- 200 packaging units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Products do not meet stability criteria and may impact results.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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