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Recall Observatory FDA recall evidence

Device product

Calibration Serum Level 3 CAL2351

Z-0752-2024

November 20, 2023

Class II

Product summary

Firm
Randox Laboratories Ltd.
Event
Event 93612
Status
Ongoing
Classification
Class II
Quantity
269 kits
Official record key
device-enforcement:Z-0752-2024

Official wording

Reason: CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

Code information: GTIN: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE

Distribution pattern: US Nationwide and Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.