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CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214

CAROLINA LIQUID CHEMISTRIES CORPORATION · Model AU-214 · UDI-DI 00817302020946

CJW Prescription
10
510(k) clearances
17
Adverse events
1
Recalls
24
Facilities

Description

ALB (Albumin) BCP 3 x 275 tests

Recalls

DateFirmReason
2019-03-18Roche Diagnostics CorporationThe reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.