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CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CA RGT KIT Product No. ST251

CAROLINA LIQUID CHEMISTRIES CORPORATION · Model ST251 · UDI-DI 00817302020403

CJY Prescription

510(k) clearances

372

Adverse events

Recalls

Facilities

Description

CA (Calcium) 4 x 200 tests

Recalls

Date	Firm	Reason
2025-07-09	Ortho-Clinical Diagnostics, Inc.	Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, cau
2025-04-24	Mckesson Medical-Surgical Inc. Corporate Office	transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2022-02-09	Siemens Healthcare Diagnostics, Inc.	Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
2018-12-04	Randox Laboratories Ltd.	Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calciu
2018-12-04	Randox Laboratories Ltd.	Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calciu
2016-05-18	Ortho-Clinical Diagnostics	Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 C
2013-09-04	SEPPIM SAS	Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.
2013-08-29	Vital Diagnostics, Inc.	High positive calcium bias on plasma sample versus results on serum
2013-08-29	Vital Diagnostics, Inc.	High positive calcium bias on plasma sample versus results on serum
2013-06-12	Ortho-Clinical Diagnostics	Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

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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.