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CRYOcheck Hex LA
Precision Biologic Inc · Model HEXLA-M · UDI-DI 00843876000596
GFO
Prescription
1
510(k) clearances
97
Adverse events
10
Recalls
15
Facilities
Description
CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-11 | Instrumentation Laboratory | Potential for microbial contamination. |
| 2025-11-18 | Instrumentation Laboratory | Recalled lots were manufactured with double the amount of preservative concentration. |
| 2021-01-05 | Helena Laboratories, Corp. | Intermittent potential for shorter than expected clot times. |
| 2018-11-14 | Diagnostica Stago, Inc. | There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. |
| 2018-11-14 | Diagnostica Stago, Inc. | There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. |
| 2017-12-07 | Helena Laboratories, Corp. | Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay. |
| 2015-03-25 | Siemens Healthcare Diagnostics, Inc. | Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. Patient samples wit |
| 2013-12-19 | ITC-Nexus Dx | ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals. |
| 2006-07-18 | Diagnostica Stago, Inc. | Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants. |
| 2004-03-01 | Dade Behring , Inc. | cloudy appearance or precipitate |
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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.