FDA Medical Device Recalls (openFDA)
Chromsystems Instruments & Chemicals GmbH: MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - 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 number
- Z-0539-2021
- Recalling firm
- Chromsystems Instruments & Chemicals GmbH
- Product
- MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - 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.
- Status
- Terminated
- Initiated
- 2020-11-02
- Posted
- not on file
- Terminated
- 2021-12-20
- Reason
- XXX
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 342 vials
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA and NY; The countries of Australia, Belgium, Brazil, Germany, Finland, France, Greece, Israel, Italy, Canada, Croatia, Kuwait, Austria, Russia, Switzerland, South Africa, Taiwan, Turkey, and United Arab Emirates.
- Lot, serial or model codes
- Order No. 0473, Lot No. 2019 (expiration 05/01/2022)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 3003951180
- Firm city
- Grafelfing
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28