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IDS-iSYS Ostase® BAP

IMMUNODIAGNOSTIC SYSTEMS LIMITED · Model IS-2800US · UDI-DI 05060169695801

CIN Prescription
1
510(k) clearances
4
Adverse events
7
Recalls
8
Facilities

Recalls

DateFirmReason
2016-07-14Diagnostic Hybrids, Inc.There is a possibility of low volume and/or leaking standard bottles.
2012-08-10Immunodiagnostics Systems LtdIt 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
2012-08-10Immunodiagnostics Systems LtdIt 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
2012-08-10Immunodiagnostics Systems LtdIt 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
2011-11-10Beckman Coulter Inc.The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified
2011-11-10Beckman Coulter Inc.The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified
2011-06-22Beckman Coulter Inc.The Access Ostase reagent lot 021281 shows instability resulting in falsely high patient results.

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Data 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.