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SPOTCHEM™ II Amylase

ARKRAY USA, INC. · Model 77113 · UDI-DI 00015482771133

CIJ
10
510(k) clearances
1
Adverse events
1
Recalls
6
Facilities

Description

Strip description for the invitro quantitative determination of amylase concentration in human plasma from whole blood samples

Recalls

DateFirmReason
2020-07-10RANDOX LABORATORIES, LTD.Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.

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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.