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Urine BETA CrossLaps® (CTX-I) ELISA
IMMUNODIAGNOSTIC SYSTEMS LIMITED · Model AC-05F1 · UDI-DI 05060169690158
JMM
Prescription
10
510(k) clearances
6
Adverse events
2
Recalls
10
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-04-25 | Roche Diagnostics Operations, Inc. | Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the sample stability given in the Elecsys -CrossLaps (-CL) assay package ins |
| 2012-08-10 | Immunodiagnostics Systems Ltd | It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the Uni |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.