Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
Brand
Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany
Lot Codes / Batch Numbers
Order No. 0471, Lot No. 2019 (expiration 05/01/2022)
Products Sold
Order No. 0471, Lot No. 2019 (expiration 05/01/2022)
Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany is recalling MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is int due to Products do not meet stability criteria and may impact results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Products do not meet stability criteria and may impact results.
Recommended Action
Per FDA guidance
Consignees are informed of this issue by Field Safety Notice FSN 03-2020 on 11/02/2020, also addressing the measures that should be taken by the consignees: If the products listed above were already used for measurements, consignees shall check with the attending physician(s) whether it is necessary to review the results of asparagine, homocystine and methionine. Consignees shall stop using the reconstituted products listed above that are stored more than 6 weeks at < -18 C for measurements of asparagine, homocystine and methionine. Consignees shall destroy the remaining stock of reconstituted calibrators and controls that are stored more than 6 weeks at < -18 C and were intended to be used in measurements of asparagine, homocystine and methionine according to their valid laboratory regulations. Chromsystems will replace stocks. Calibrators and controls will now have a reduced in-use stability (after reconstitution) for asparagine, homocystine and methionine of 6 weeks at < -18 C. For all other analytes, in-use stability is not changed. If consignees have forwarded any of the products listed above to another laboratory, consignees shall inform that laboratory of the content of this letter and forward a copy. Consignees shall document their measures on provided Response document (attachment Response) and return their response until 20.11.2020 to Chromsystems (contact details provided in the attachment Response). Consignees shall make sure that all users of the products mentioned above and other persons affected in their organization are informed about the FSN. If they have provided third parties with these products, they shall forward a copy of this information or inform the contact person of Chromsystems.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026