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Starrsed Control QRR049002Recalls & reported problems

RR Mechatronics Manufacturing B.V. · Control blood for Starrsed Instruments and procedures · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Apr 14, 2023Open, Classified

    QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range.

    Z-1695-2023 · Root cause: Labeling Change Control · FDA record ↗

Other DEVICE, AUTOMATED SEDIMENTATION RATE devices

All DEVICE, AUTOMATED SEDIMENTATION RATE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.