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DiaSpect Control Pack HBT2
DiaSpect Medical GmbH · Model 90B.0012 · UDI-DI 04048534001564
GGM
Prescription
10
510(k) clearances
2
Adverse events
2
Recalls
17
Facilities
Description
For the verification of the precision and accuracy of DiaSpect Hemoglobin Analyzer and DiaSpect Hemoglobin Cuvettes
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-10-18 | EUROTROL INC | Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values |
| 2018-10-18 | EUROTROL INC | Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values |
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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.