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Spinalscopics Control Level 1 Set 3x3mL

QUANTIMETRIX CORPORATION · Model 1461-31 · UDI-DI 00896863002080

510(k) clearances

Adverse events

Recalls

Facilities

Description

Spinalscopics Spinal Fluid Cell Count Control is intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient CSF samples. Total cell counts are performed in a counting chamber with undiluted CSF. They are supplied in two levels, 3x3mL bottles per level per box. The controls are ready-to-use liquid, requiring no reconstitution or dilution. They are prepared in a human protein matrix fortified to target levels with purified chemicals and stabilized human red and white blood cells. Preservatives have been added to inhibit microbial growth.

Recalls

Date	Firm	Reason
2022-11-07	R & D Systems, Inc.	For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
2021-10-05	Primus Corporation dba Trinity Biotech	The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacce
2021-10-05	Primus Corporation dba Trinity Biotech	The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value
2021-01-25	Medline Industries Inc	Product was compromised during shipment.
2020-10-05	Becton, Dickinson and Company, BD Biosciences	Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
2013-02-24	Clinical Diagnostic Solutions	Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
2012-09-14	Horiba Instruments, Inc dba Horiba Medical	HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High)
2011-03-24	Clinical Diagnostic Solutions	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; an
2011-03-24	Clinical Diagnostic Solutions	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; an
2011-03-24	Clinical Diagnostic Solutions	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; an

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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.