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Micro pipette, plastic EDTA
Boule Medical AB · Model Micro pipette, plastic EDTA 1x100 · UDI-DI 07350040790687
10
510(k) clearances
42
Adverse events
25
Recalls
62
Facilities
Description
Accessory for the MPA use in Medonic M-series, Swelab Alfa-series, and Boule 950-series hematology analyzer for blood collection from a finger stick or a venous blood sample and direct insertion into the Micro Pipette Adapter (MPA) inlet of Medonic M-series, Swelab Alfa-series, and Boule 950-series automated hematology analyzers.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
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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.