{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184388", "product_res_number": "Z-0538-2021", "event_date_initiated": "2020-11-02", "event_date_created": "2020-12-04", "recall_status": "Terminated", "event_date_terminated": "2021-12-20", "res_event_number": "86719", "product_code": "JJY", "product_description": "MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - 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.", "code_info": "Order No. 0472, Lot No. 2019 (expiration 05/01/2022)", "firm_fei_number": "3003951180", "recalling_firm": "Chromsystems Instruments & Chemicals GmbH", "address_1": "Am Haag 12 12 am haag", "city": "Grafelfing", "country": "Germany", "reason_for_recall": "XXX", "root_cause_description": "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:\nIf 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.\n\nConsignees 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.\n\nConsignees 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.\n\nIf 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.\n\nConsignees 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).\n\nConsignees 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.", "product_quantity": "363 vials", "distribution_pattern": "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.", "openfda": { "k_number": [ "K944452", "K993014", "K760818", "K990161", "K030482", "K051185", "K062668", "K122838", "K023250", "K833639", "K082067", "K971657", "K972235", "K960862", "K882728", "K833423", "K931373", "K102157", "K023669", "K945315", "K961359", "K102700", "K041361", "K071433", "K923663", "K935219", "K950326", "K134013", "K800558", "K972608", "K983166", "K955812", "K972904", "K090541", "K111063", "K101809", "K901212", "K874459", "K790264", "K082107", "K792024", "K863648", "K872777", 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