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Pneumococcus Anti CWPS high titer, 1 mL
Ssi Diagnostica A/S · Model 91304 · UDI-DI 05713106913048
10
510(k) clearances
370
Adverse events (5 deaths)
20
Recalls
52
Facilities
Description
Rabbit antiserum, High titer
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-06 | Quidel Corporation | Product has the potential for false positive results |
| 2025-12-19 | Altruan GmbH | Product not cleared by the FDA. |
| 2025-12-19 | Altruan GmbH | Product not cleared by the FDA. |
| 2025-12-19 | Altruan GmbH | Product not cleared by the FDA. |
| 2025-07-30 | Mckesson Medical-Surgical Inc. Corporate Office | Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such device |
| 2025-06-17 | Quidel Corporation | Dipstick strep A test has potential for false positive results. |
| 2024-08-20 | Cypress Medical Products LLC | Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices. |
| 2024-04-22 | Wondfo USA Co Ltd | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for |
| 2024-04-22 | Wondfo USA Co Ltd | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for |
| 2024-04-22 | Wondfo USA Co Ltd | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for |
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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.