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Cell-Chex Auto
STRECK, INC. · Model 200065 · UDI-DI 00844509000587
1
510(k) clearances
93
Adverse events
16
Recalls
31
Facilities
Description
Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 1 vial each of level 2 & 3.
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. The unacceptable Control Level 1 value |
| 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 |
| 2021-01-25 | 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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Get your free API keyRead the docsData 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.