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IDS Beta CrossLaps® (CTX-I)
IMMUNODIAGNOSTIC SYSTEMS LIMITED · Model IS-3000N · UDI-DI 05060169695986
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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