Recall Z-0538-2021 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Chromsystems Instruments & Chemicals GmbH
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.
| Date | Nov 2, 2020 |
| Status | Terminated |
| 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 reconstitut |
| Quantity | 363 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.