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HomeCAROLINA LIQUID CHEMISTRIES CORPORATION › CAROLINA LIQUID CHEMISTRIES CORP.™ BUN REAGENT 88806

CAROLINA LIQUID CHEMISTRIES CORP.™ BUN REAGENT 88806

CAROLINA LIQUID CHEMISTRIES CORPORATION · Model 88806 · UDI-DI 00817302020397

CDS Prescription
10
510(k) clearances
7
Adverse events
1
Recalls
13
Facilities

Description

BUN3 (Blood Urea Nitrogen) - CX3 Reagent 1 x 500 mL

Recalls

DateFirmReason
2016-10-31Roche Diagnostics Operations, Inc.Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue

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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.