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Aptima®
Hologic, Inc. · Model HOLOGIC SPECIMEN LYSIS TUBE, SOLID CAP · UDI-DI 25420045513720
NNI
Prescription
0
510(k) clearances
41
Adverse events
4
Recalls
333
Facilities
Description
Tray of Specimen Lysis Tubes, Solid Cap, 50 tubes.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-09 | Milestone S.R.L. | There is a possibility of reagent leakage from the specimen container. |
| 2021-12-01 | MEDLINE INDUSTRIES, LP - Northfield | Product stored incorrectly in temperature controlled setting instead of refrigeration. |
| 2016-03-03 | Dynarex Corporation | Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton. |
| 2011-02-18 | Cardinal Health Inc | In one lot of product (lot# 1091745), the label for the small version of the sock (catalog number 65652-123) was improperly used for the larger version of the product (65652-124) |
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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.